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

Model Number 174025

Device Problem Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic inguinal hernia repair, while tacking the mesh in place, the surgeon fired the device but it could not fire.They could not give a full squeezed to the handle.They used another device to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted the handle was partially retracted.The device loading unit (dlu) was received preloaded with a tack in the e piece.No damage was noted to the e piece.Functionally, the device was able to rotate properly.The tack was removed from the e piece.During firing, the tacks seated properly, but handle did not retract after firing.The leaf spring was loose on handle.  the unit was disassembled 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 medtronic 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.  a process improvement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE ENDO HERNIA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8188983
• MDR Text Key: 131134326
• Report Number: 2647580-2018-06225
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070599
• UDI-Public: 20884521070599
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 174025
• Device Catalogue Number: 174025
• Device Lot Number: P7F1155X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1