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

Model Number IPN915189

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

When the user attempted to ligate a clip during a surgery the clip was not locked.He/she had to try several times to lock the clip properly.Then when he/she removed the applier the clip stuck in the applier.Therefore, the applier was replaced with another one to complete the surgery.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha wi facility as part of a (b)(4) pc.Lot in march of 2020.This instrument was returned without its luer flush port cap.Evaluation of the returned instrument shows that the there is no visible damage to the outer tube assembly where the jaws are attached.Functional testing of this instrument shows that this instrument is able to pick-up , retain, close and release multiple clips both with and without the use of silastic test tubing.We are unable to validate this complaint since we are unable to replicate the alleged issue.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.

Event Description

When the user attempted to ligate a clip during a surgery the clip was not locked.He/she had to try several times to lock the clip properly.Then when he/she removed the applier the clip stuck in the applier.Therefore, the applier was replaced with another one to complete the surgery.

• 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: 12728797
• MDR Text Key: 279307511
• Report Number: 3011137372-2021-00299
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696813
• UDI-Public: 24026704696813
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915189
• Device Catalogue Number: 544965
• Device Lot Number: 06F1989611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• 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