MAUDE Adverse Event Report: TELEFLEX MEDICAL MEDIUM HEMOLOK TAKEAPART APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN915188
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the jaws of the applier were found misaligned during a surgery.Therefore, another applier was used to complete the procedure.No clip fell/remained in the patient".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the jaws of the applier were found misaligned during a surgery.Therefore, another applier was used to complete the procedure.No clip fell/remained in the patient".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturer (kosher & wurtz gmbh) for investigation.The manufacturer reported: "the insert was not sent in for examination.The instrument was incomplete.We could not perform a functional test to reproduce and understand the problem.No root cause analysis possible as instrument was returned incomplete.No further measures will be initiated by k & w." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: MEDIUM HEMOLOK TAKEAPART 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: 17318163
• Report Number: 3011137372-2023-00192
• Device Sequence Number: 12291058
• Product Code: GDO
• UDI-Device Identifier: 24026704709902
• UDI-Public: 24026704709902
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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 Model Number: IPN915188
• Device Catalogue Number: 544945T
• Device Lot Number: G9-04
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/18/2023
• 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