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

Model Number IPN915189

Device Problem Material Separation (1562)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The jaws were found broken during a pretest before use.Also, the pivot pin was detached.The applier were purchased by the hospital within 1 year.

Event Description

The jaws were found broken during a pretest before use.Also, the pivot pin was detached.The applier were purchased by the hospital within 1 year.

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 june of 2020.Evaluation of the returned instrument shows that the tips are bent to one side and loose and misaligned, (pie's attached) and the jaw pivot pin is pushed thru one side of the damaged/bent outer tube assembly.We are able to validate this complaint.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod (n00185) is bent/damaged, and its bosses are both damaged where they engage the jaws.We are unable to determine how the drive rod (n00185) became bent/damaged and for the drive rod bosses to become damaged and for the jaws to become loose and misaligned and for the jaw pivot pin to be pushed thru one side of the outer tube assembly but mishandling 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: 12727910
• MDR Text Key: 279278991
• Report Number: 3011137372-2021-00310
• 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: 06B2098690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• 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