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

Model Number	174021
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of two devices.The first device was received with the handle partially retracted.The dlu was received partially applied with a tack in the e piece.No damage was noted to the e piece.A visual inspection of the second instrument noted no abnormalities.The dlu was received fully applied.No damage was noted to the e piece.Functionally, both devices were able to rotate properly.A test dlu was loaded onto the instruments.With both instruments, the tacks seated properly, but the handle did not retract after firing.The leaf spring was loose on the handle.The units were opened as instructed by engineering and it was noted the leaf spring was detached and rolled.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.The root cause of the reported condition is due to an excessive amount of adhesive being applied to the spring retainer during the assembly process.The additional adhesive prevented the spring retainer from properly functioning and resulted in it breaking.A broken spring retainer will prevent the return of the handle after actuating, thus preventing the unit from firing.The product analysis established a relationship between a device failure and the reported incident of instrument did not fire.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process improvement has been initiated to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Event or Problem Description
According to the reporter, during an inguinal hernia procedure, while being applied for the mesh fixation, the device partially fired.Another device was used in order to complete the case.There was no patient injury.

• 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: 7589142
• Report Number: 2647580-2018-02826
• Device Sequence Number: 2074026
• Product Code: GCJ
• UDI-Device Identifier: 10884521070561
• UDI-Public: 10884521070561
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K912097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: 07/31/2022
• Device Model Number: 174021
• Device Catalogue Number: 174021
• Device Lot Number: P7G1532X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1