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 09/28/2021

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

It was reported that the jaws of the applier did not open enough during a surgery.Therefore, it was replaced with another one.No reported patient injury.

Event Description

It was reported that the jaws of the applier did not open enough during a surgery.Therefore, it was replaced with another one.No reported patient injury.

Manufacturer Narrative

Qn#(b)(4).The dhr for the returned instrument was evaluated and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50-piece lot in april of 2020.Evaluation of the returned instrument as received shows that the laser marking on the outer tube assembly is 180 from its correct print location and the luer flush port is not tightened down all the way into the knob assembly and the open jaw gap is undersized.We are able to validate this complaint.Further evaluation shows that when the luer flush port was removed and the tube assembly was rotated 180 and the luer flush port was re-installed the open jaw gap was returned to its proper print specification of (.280 +/-.025") at.274".Function testing after the luer flush port cap was re-installed shows that this instrument is now able to pick-up, retain, close and release multiple clips both with and without the use of the silastic test tubing.We are unable to determine what caused the (weck 5mm) laser marking on the tube assembly to become positioned 180 from its proper location and for the luer flush port to be slightly loose and for the open jaw gap to be undersized but it is suspected that this instrument has been mishandled at the end user's facility.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: 12632884
• MDR Text Key: 276408227
• Report Number: 3011137372-2021-00294
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 06G1990520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• 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
• Treatment: N/A.