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

Catalog Number	544965T
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tip of the applier got torn off when ligating a clip and the broken pieces fell in the abdominal cavity during a ralp.The user withdrew all the visible fragments from the abdominal cavity, replaced the applier with a new one and completed the surgery.No injury to the patient was reported".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "during visual examination, we found the following: broken pin and pull rod in jaw area.Bent pull rod in handle area.Upon review of the device history records for the affected lor number, we can confirm that both the correct material and correct components have been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.The breakage of the pin and the pull rod and the bending of the pull rod were caused by great force with the handle.Incorrect handling of the instrument with too much force.At k and w, no further measures will be initiated; this complaint is being rejected by us." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "the tip of the applier got torn off when ligating a clip and the broken pieces fell in the abdominal cavity during a ralp.The user withdrew all the visible fragments from the abdominal cavity, replaced the applier with a new one and completed the surgery.No injury to the patient was reported".

• Brand Name: WECK HEMOLOK TAKEAPART 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: 20543918
• Report Number: 3011137372-2024-00169
• Device Sequence Number: 20790477
• Product Code: GDO
• UDI-Device Identifier: 24026704697841
• UDI-Public: (01)24026704697841(11)230503(17)001212(10)P32243495(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 544965T
• Device Lot Number: P32243495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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