MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 173054

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2019

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 a laparoscopic hernia repair procedure, there were 4 device that did not fire.Additional device was used to complete the procedure.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 advanced.The device loading unit (dlu) was received preloaded with a tack in the e piece.No damage was noted to the e piece.During test firing, the tacks seated properly, but the handle did not retract after firing due to a broken leaf spring.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault 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 root cause of the observed condition was determined to be a result of a manufacturing activity.Process improvements have been made to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic hernia repair procedure, two devices did not fire.Additional device was used to complete the procedure.There was no patient injury.

• Brand Name: ENDO UNIVERSAL 65
• 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: 9166695
• MDR Text Key: 161551605
• Report Number: 2647580-2019-05007
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070530
• UDI-Public: 10884521070530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 173054
• Device Catalogue Number: 173054
• Device Lot Number: P7D0077X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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