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

Model Number	030805L
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
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 a laparoscopic donor nephrectomy, the stapler was fired on the ureter without incident then the stapler was reloaded and fired on the renal artery.When the stapler was opened, severe bleeding of more than 500cc was observed and there was interruption of the staple line.The laparoscopic procedure was converted to open; the kidney was removed for transplantation and the renal artery tissue was hand sewn and trimmed to stop the bleeding.Blood transfusion was required, surgical time and incision was extended and an x-ray was also done to determine if any components were left behind.
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 a laparoscopic donor nephrectomy, the stapler was fired on the ureter with out incident then the stapler was reloaded with the and fired on the renal artery.When the stapler was opened, severe bleeding of more than 500cc was observed as well as a staple line interruption and no complete staples observed on the staple formation.The laparoscopic procedure was converted to an open; the kidney was removed for transplantation and the renal artery tissue was hand sewn and trimmed to stop the bleeding.Blood transfusion was required, surgical time and incision was extended and an x-ray was also done to determine if any components were left behind.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Nicks were observed on the knife blade.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 observed damage may occur if the instrument is applied over an obstruction.The instructions for use also states: when positioning the instrument on the application site ensure that no obstructions such as previously clips are incorporated into the instrument jaws.Firing over an obstruction may result in improperly formed staples.Improperly formed staples may result in leakage or disruption of the staple line.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.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: MULTIFIRE ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7495791
• Report Number: 2647580-2018-02346
• Device Sequence Number: 18880617
• Product Code: GDW
• UDI-Device Identifier: 20884523003762
• UDI-Public: 20884523003762
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K900129
• 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): 01/14/2019

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 Expiration Date: 10/31/2022
• Device Model Number: 030805L
• Device Catalogue Number: 030805L
• Device Lot Number: P7K0843MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 12/17/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 12/06/2018; 01/14/2019
• 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
• Patient Age: 68 YR