MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIATRS60AMT

Device Problems Misfire (2532); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic low anterior resection/proctectomy, at the first firing, the surgeon clamped the tissue, squeezed the handle, and pressed the green button, then fired the device.Though he fully squeezed the handle continuously for the last, the anchoring suture which fastened the tip of the sheet was not cut.Moreover, stapling wasn't able to be performed in 1-2 cm from the distal end.The procedure was completed with another device.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was partially fired.Staple pushers were visible at the 1cm cut line.Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade.The clamping mechanism was deformed.The anvil was bowed.The distal sutures were properly engaged.The trs material was manually cut by the account.The reload was loaded into a post market vigilance instrument for functional testing.The interlock was overridden and the reload was cycled without hesitation or binding and was applied to test media.All remaining staples were placed and test media was cleanly transected.Functional testing confirmed the safety interlock feature successfully prevented the reload from cycling again.The distal sutures were properly disengaged.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the damaged knife blade may occur when an obstacle has been incorporated in the jaws during application.The information booklet which accompanies each product shipment cautions the user; ensure that no obstructions (such as clips) are incorporated in the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.Replication of the bowed anvil, deformed anvil clamping mechanism and partially flushed staple pushers.Application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly and tissue may not be fully transected.The information booklet which accompanies each product shipment offers the following as a warning and precaution." preoperative radiotherapy may result in changes to tissue.These changes may, for example, cause the tissue thickness to exceed the indicated range thickness for the staple size.Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8342614
• MDR Text Key: 136233196
• Report Number: 1219930-2019-00896
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884521191010
• UDI-Public: 20884521191010
• Combination Product (y/n): N
• PMA/PMN Number: K133938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: EGIATRS60AMT
• Device Catalogue Number: EGIATRS60AMT
• Device Lot Number: N7K0850KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/15/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1