MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544965

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation report has not been submitted at this time.Teleflex will continue to monitor and trend related events.

Event Description

Issue reported: during a laparoscopic cholecystectomy when the physician went to apply a 3rd clip across the cystic duct the applier jaws broke enabling the device to further be used.There was no patient injury.He did mention he was unsure if a prior clip that was already in place on the cystic duct had got in the way.

Manufacturer Narrative

(b)(4).The dhr for the alleged instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) facility as part of an 50 pc.Lot in may of 2017.The returned instrument was evaluated and as received the tube assembly where the jaws are attached is bent/damaged and the jaws are loose and misaligned and the jaw pivot pin is slightly popped and sticking out on one side of the tube assembly and the drive rod is bent at jaw end.Parts were 100% visually inspected and tested at the (b)(4) facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.At this time it is un-determined what caused the tube assembly where the jaws are attached to be bent/damaged and the jaws to be loose and misaligned and the jaw pivot pin to be slightly popped and sticking out on one side of the tube assembly but mishandling at the customers facility is suspected.No corrective action required at this time.

Event Description

Issue reported: during a laparoscopic cholecystectomy when the physician went to apply a 3rd clip across the cystic duct the applier jaws broke enabling the device to further be used.There was no patient injury.He did mention he was unsure if a prior clip that was already in place on the cystic duct had got in the way.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7125528
• MDR Text Key: 95196363
• Report Number: 3011137372-2017-00388
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06M1644496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1