MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM 45CM; APPLIER, SURGICAL, CLIP

Model Number IPN915198

Device Problem Difficult to Open or Close (2921)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

After smooth loading, the user was unable to ligate a clip during a surgery.Therefore, he/she replaced the applier with a new one.

Manufacturer Narrative

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

Event Description

After smooth loading, the user was unable to ligate a clip during a surgery.Therefore, he/she replaced the applier with a new one.

Manufacturer Narrative

Qn#(b)(4).Per customer submitted information the dhr for the alleged instrument was reviewed and found completely without any irregularities.The alleged instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4) pc.Lot in august of 2021.It was found that this order was made from the correct materials and components.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing process.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.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.

• Brand Name: HOL L ENDO APPLIER 10MM 45CM
• 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: 15112116
• MDR Text Key: 304522141
• Report Number: 3011137372-2022-00138
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704697896
• UDI-Public: 24026704697896
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915198
• Device Catalogue Number: 544995L
• Device Lot Number: 06K2005216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1