MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO TA; STAPLE, IMPLANTABLE

Model Number	010911L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic donor nephrectomy (left side), the device was able to fire, but the staples on the reload and tissue are malformed.The doctor fired the device on the renal vein (3rd firing).On first firing, ureter, second, renal artery, third: rental vein.Upon completion of firing, the doctor attempted to open the stapler but the tissue/staples were stuck to the reload.The doctor was able to fire two clips below the jaws of the reload and had to cut the tissue to remove the tissue from the stapler.There was unanticipated tissue loss and tissue damage a result of the issue.A loss of 1-2mm tissue was noted.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of a photo of a device.Staple formation issues were observed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE ENDO TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7465169
• Report Number: 2647580-2018-02118
• Device Sequence Number: 11161017
• Product Code: GDW
• UDI-Device Identifier: 20884521047768
• UDI-Public: 20884521047768
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K910192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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 Expiration Date: 09/30/2021
• Device Model Number: 010911L
• Device Catalogue Number: 010911L
• Device Lot Number: P6J0362MX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 08/08/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 07/30/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR