MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML ENDO APPLIER 5MM 45CM; APPLIER, SURGICAL, CLIP

Catalog Number	544965L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "while finishing a procedure the rod that attaches the tip of the clip applier broke off with no prior damage being present".Additional information received states that "the rod that attaches the top of the clip applier broke off".The patient status is reported as "unharmed, there were no fragments in the patient".
Additional Manufacturer Narrative
(b)(4).N/a other remarks: n/a corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).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 25-pc.Lot in october of 2023.It was found that this order was made from the correct materials and components and all approved processes were followed.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.Evaluation of the returned instrument shows that the jaws and jaw pivot pin are loose from the tube assembly.Further evaluation shows that the tube assembly area and drive rod are both bent/damaged.We are able to validate this complaint for the returned instrument.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 bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned, but we are unable to determine what caused the drive rod and outer tube assembly to become bent/damaged and for the jaws and pivot pin to become separated from the outer tube assembly but mishandling of this device at the end user's facility is suspected.All 25 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "while finishing a procedure the rod that attaches the tip of the clip applier broke off with no prior damage being present".Additional information received states that "the rod that attaches the top of the clip applier broke off".The patient status is reported as "unharmed, there were no fragments in the patient".

• Brand Name: HOL ML ENDO APPLIER 5MM 45CM
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18485201
• Report Number: 3011137372-2024-00012
• Device Sequence Number: 9077859
• Product Code: GDO
• UDI-Device Identifier: 34026704622499
• UDI-Public: 34026704622499
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 544965L
• Device Lot Number: 06C2359420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown