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

Model Number 174025

Device Problems Failure to Fire (2610); Mechanical Jam (2983)

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

Event Date 01/24/2018

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 bariatric bypass, when being used for closing the mesentery, the device did not fire and it was jammed.Staples did not deploy.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.The device loading unit (dlu) was received partially applied.Functionally, the device was able to rotate properly.The handle could be actuated, but did not retract.The leaf spring was loose on handle.The unit was 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.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7280827
• MDR Text Key: 100481969
• Report Number: 2647580-2018-00839
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521070599
• UDI-Public: 20884521070599
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

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
• 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: 02/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 03/16/2018; 04/20/2018
• Supplement Dates FDA Received: 04/13/2018; 04/30/2018
• 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