MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE VERSATACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174021
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
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, pre-operatively on a bilateral inguinal hernia repair procedure, the device could not fire and zero staples came out.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The e-piece was damaged on one side.The device loading unit (dlu) was received with six tacks remaining.The instrument was applied to the appropriate test media.The handle was actuated and the remaining six tacks deployed but did not seat properly due to the damaged e piece.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 reported condition may occur as a result of excessive manipulation of the device.The root cause of the observed damage was found to be due to the device not being used as intended 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 VERSATACK
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8706011
• Report Number: 2647580-2019-03093
• Device Sequence Number: 1992228
• Product Code: GCJ
• UDI-Device Identifier: 20884521070568
• UDI-Public: 20884521070568
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K912097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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 Expiration Date: 06/30/2022
• Device Model Number: 174021
• Device Catalogue Number: 174021
• Device Lot Number: P7F0199X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1