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

Model Number 174027

Device Problems Component Missing (2306); Failure to Fire (2610)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the device is defective at first use; 0 staples came out.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one endo hernia universal instrument.  a visual inspection noted the handle was jammed and partially actuated.  during functional testing, 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.

Event Description

According to the reporter, during hernia procedure, no clips came out of the instrument.It was empty.There was no patient injury.

Manufacturer Narrative

Additional information: evaluation summary post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the first instrument noted no abnormalities.A partially applied device loading unit (dlu) was received preloaded on the instrument.Visual inspection of the second instrument noted no abnormalities.No dlus were received.Functionally, both devices were able to rotate properly.The first instrument was applied to the appropriate test media.During firing, the tacks seated properly, but handle did not retract after firing.The leaf spring was loose on handle.The second instrument handle could be actuated but did not fully retract.Both units were opened as instructed by engineering and it was noted the leaf spring was detached and rolled.Additionally, both spring retainers were broken.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 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.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: 8082887
• MDR Text Key: 127551861
• Report Number: 2647580-2018-05593
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070608
• UDI-Public: 10884521070608
• 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: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2018
• 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: 174027
• Device Catalogue Number: 174027
• Device Lot Number: P7F1221X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• 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