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

Model Number IPN028280

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

This applier faced an issue during a cholecystectomy/coelio.The pin connecting the jaws to the rest of the applier broke off when the second clip was loaded.It went in inside the patient's abdominal cavity.The applier worked properly when applying the 1st clip.After a careful search for the pin, it was not found.It may have been sucked in (removed) but we are not sure.

Event Description

This applier faced an issue during a cholecystectomy/coelio.The pin connecting the jaws to the rest of the applier broke off when the second clip was loaded.It went in inside the patient's abdominal cavity.The applier worked properly when applying the 1st clip.After a careful search for the pin, it was not found.It may have been sucked in (removed) but we are not sure.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was originally produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4) pc.Lot in october of 2018.Evaluation of the returned instrument shows that engraving location is different than when produced and there is additional lot coding of r-04-22 on the side of the proximal handle which indicates that this instrument has been sent in for repair prior to this complaint.Further evaluation shows that the tips are bent to one side and loose and misaligned, and the jaw pivot pin is pulled thru one side of the damaged/bent outer tube assembly.We are able to validate this complaint.We are unable to determine what caused the jaws to be bent to one side and to be loose and misaligned and for the jaw pivot pin to be pulled thru one side of the bent/damaged outer tube assembly but mishandling of this device at the end user's facility is suspected.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 15142412
• MDR Text Key: 304191704
• Report Number: 3011137372-2022-00163
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696813
• UDI-Public: 24026704696813
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

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 Model Number: IPN028280
• Device Catalogue Number: 544965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1