Covidien Endo GIA (sewing the device)

The rechargeable endoscopic devices intended for automatic suture on abdominal organs are Covidien Endo GIA Universal Auto Suture.

2019: The next withdrawal of the rejected devices causing bleeding

At the beginning of June, 2019 the Medtronic company announced the next response from the market of the surgical staplers Endo GIA — this time in connection with defects of disposable boot blocks of intelligent devices of a recharge of Tri-Staple 2.0 and cartridges. According to the notification from the producer, use of the faulty sewing devices can lead to development of bleedings and other serious complications.

The revealed production violations became the reason – the company voluntarily recalls staplers as in them there can be no one of two contact components intended for alignment of the shock mechanism. Use of the device with the absent pin can lead to creation of a defective seam and to become the reason of bleeding, discrepancy of an anastomoz, peritonitis or pheumothorax. In turn, these complications can lead to accession of an infection or sepsis that threatens with a lethal outcome.

The surgical stapler Endo GIA can cause bleedings

The company stated that it revealed the rejected devices during production process quality check. According to the statement of Medtronic, responsible persons already took measures for the solution of this problem. From users of complaints on the matter did not arrive yet. The notification of the company concerns EGIA30AMT, EGIA45AVM, EGIA45CTAMT, EGIA60AXT, EGIA60CTAMT, SIG30AMT, SIG45AXT, SIG45CTAMT, SIG60AXT, SIG60CTAMT, EGIA45AMT and EGIA60AMT devices which were released during the period from April, 2014 to April, 2019. Earlier the company already recalled the surgical staplers Endo of other models.

Medtronic offered clients who bought defective products, as soon as possible to stop its use, to isolate devices and to return the companies. For this purpose Medtronic sent to all clients the express notices concerning security.^[1]

2018: A withdrawal of the rejected devices

On May 8, 2018 the Medtronic company announced a voluntary withdrawal of job lots of the device Covidien Endo GIA. The company reported that in devices of some batches there is not enough component which is responsible for fixing of brackets. Use of the device without this component does not allow to pull together and fix adequately edges of a wound that leads to bleeding or penetration into an abdominal cavity of contents of hollow bodies. Medtronic received four messages about adverse effects of this defect.

Medtronic recalls the rejected sewing devices because of bad tightening of cuts

According to the notification on security of a product in the European Union 44 codes of damaged goods Endo GIA and 179 rejected batches were revealed, and 9 more codes and 95 series were revealed on the rest of the world. The voluntary response concerns only those batches of devices which are listed in the A and B appendices corresponding the notification on security. Medtronic asks that buyers immediately stopped use of these devices, and all rejected copies should be withdrawn from work and to return to the seller according to the notification even if they yet were used by nobody. Besides, the Medtronic company recommends to the distributors to convey this information to buyers as soon as possible.

Data retrieveds and information on the taken measures is already conveyed to the relevant competent authorities of your country, said in the notification on security of the devices Covidien Endo GIA. — Save the copy of this notification in the records. At emergence of any problems with quality or at development of ghost effects we ask you to contact representatives of Medtronic immediately. We regret for any inconveniences caused to you and we appreciate with what attention you treat this problem. Safety of patients – one of priority problems of our production. In case of any questions concerning this message, address representatives of Medtronic in your country.[2]

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