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

Model Number	010911L
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter during a right hand-assisted nephrectomy, no staples were able to be deployed when fired and the artery leaked considerable blood.Medical or surgical intervention was needed to prevent permanent impairment of function.The surgeon used suture to control the bleeding and complete the case.There was blood loss of 500cc or more.However, blood transfusion was not required.Current patient status is alive with no injury.No reinforcement material was used.No other patient adverse events were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Post market vigilance (pmv) received two devices.The visual inspection of the returned products noted that the visual inspection of the cartridges noted the sulus were fully applied.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the devices had acceptable results.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.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• 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: 6670086
• Report Number: 2647580-2017-05635
• Device Sequence Number: 13712856
• Product Code: GDW
• UDI-Device Identifier: 20884521047768
• UDI-Public: 20884521047768
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K013860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2018

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: 09/30/2021
• Device Model Number: 010911L
• Device Catalogue Number: 010911L
• Device Lot Number: P6J0362MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 05/31/2017; 11/13/2017; 12/15/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 09/07/2017; 12/13/2017; 01/09/2018
• 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: Other; Required Intervention
• Patient Age: 44 YR