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

Model Number	EGIAADAPTXL
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic sleeve gastrectomy procedure, for the 2nd firing on the stomach, the device did not advance and unable to fire.The handle was replaced with a manual handle to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and functional evaluation of the handle noted no abnormalities.Evaluation of the eeprom noted that the code "drive_motor_excessive_load_mode" was present.This was indicative of a thick tissue application and could confirm the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.The file was concluded to be the device not being used as intended.Replication of the drive_motor_excessive_load_mode error codes may occur of the idrive ultra powered handle stops firing before the lower clamp reaches the distal end, which is likely due to the firing force reaching the upper design limit of the endo gia reload.This may occur under the following conditions.Application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In either scenario, staples may not form properly and tissue may not be fully transected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7781523
• Report Number: 1219930-2018-04467
• Device Sequence Number: 16523149
• Product Code: GDW
• UDI-Device Identifier: 10884521201989
• UDI-Public: 10884521201989
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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
• Operator of Device: Health Professional
• Device Model Number: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1