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

Catalog Number	544965
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "it was reported that the applier jaws were found misaligned before use.Therefore, a new unit was used instead" no patient involvement.
Additional Manufacturer Narrative
Qn #(b)(4).
Event or Problem Description
It was reported "it was reported that the applier jaws were found misaligned before use.Therefore, a new unit was used instead" no patient involvement.
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "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 (b)(4) pc.Lot in july of 2022.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 processes.Evaluation of the returned device as received shows that the jaws are slightly loose and misaligned to each other in the closed position.There is no visible damage to the jaw pivot pin area on the outer tube assembly.Further evaluation showed that both the handle to jaw and knob rotation mechanisms were dry and sluggish feeling and in need of proper lubrication.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 (n00185) 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 in the closed position.We are unable to determine what caused the drive rod bosses to become damaged and for the handle to jaw and knob rotation mechanisms to be dry and sluggish feeling but lack of proper lubrication and mishandling such as excessive force being applied to the handle to jaw mechanisms of this device at the end user's facility is suspected.All (b)(4) instruments from this lot were 100% visually inspected and function tested and properly lubricated 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." teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HOL ML 5MM ENDO APPLIER
• 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: 20216827
• Report Number: 3011137372-2024-00142
• Device Sequence Number: 7877031
• Product Code: GDO
• UDI-Device Identifier: 34026704623625
• UDI-Public: (01)34026704623625(11)220715(17)001231(10)06D2247825(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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
• Device Catalogue Number: 544965
• Device Lot Number: 06D2247825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown