MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Model Number IPN915197

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the screw of the handle was found loose when checking it at the hospital supply room.No patient involvement.

Manufacturer Narrative

Qn# (b)(4).The sample was returned and sent to the manufacturing site (tecomet) for investigation.Tecomet reports "the dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50-pc.Lot in september of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument as received shows that the endo handle pivot screw (n00186) is easily backed out of its threading which signifies that the staking operation that holds the screw in place in between the g00436m handle has failed.Further evaluation shows that the staking operation has been performed at the time of manufacture.We are unable to determine what cause the screw to become loose from its staking operation since we do not know how this instrument has been handled out in the field since its date of production.Mishandling of this device at the end user's facility is suspected.All 50 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.".

Event Description

It was reported that the screw of the handle was found loose when checking it at the hospital supply room.No patient involvement.

• Brand Name: HOL L 10MM 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17321358
• MDR Text Key: 319109079
• Report Number: 3011137372-2023-00186
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696837
• UDI-Public: 24026704696837
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915197
• Device Catalogue Number: 544995
• Device Lot Number: 06K2005185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: N/A.; N/A.