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

Model Number	EGIAADAPTXL
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a robotic laparoscopic radical nephrectomy, on the hilum of kidney, the device was a powered stapler and stopped firing about 20mm down the 60mm reload.The surgeon determined that they needed to open since they could not 100% confirm that all staples would be completely b-shaped over the tissue.The surgeon did not want to take in excessive bleeding occurring laparoscopically.The surgeon opened and retracted knife blade of the device and vessels were still intact and no bleeding on the hilum.The surgeon continued with procedure and used manual staplers with reload to take the vessels and remove the kidney.The staple line was incomplete distally.The stapler was partially fired.The surgical time was extended by 30 minutes or more because the surgeon had to convert to open procedure and the incision was extended by more than 1 inch.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No visual abnormalities were noted.A pmv representative single use loading unit (sulu) was inserted onto the adapter with a pmv drive handle and battery.The green light signaling the attachment of the adapter illuminated indicating that the adapter was recognized.The reload cycled properly and was applied to test media where it was able to apply the staple line and transect the media without difficulty.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 7891237
• Report Number: 1219930-2018-05115
• Device Sequence Number: 1837556
• Product Code: GDW
• UDI-Device Identifier: 10884521201989
• UDI-Public: 10884521201989
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: C2016K877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 09/19/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention