MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL APPLIER XL 11" RA; APPLIER, SURGICAL, CLIP

Catalog Number	544192
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: corrected data:.
Event or Problem Description
It was reported that prior to use, it was found the applier jaws are misaligned.No patient involvement.
Event or Problem Description
It was reported that prior to use, it was found the applier jaws are misaligned.No patient involvement.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as the sample was not returned for analysis.Dhr investigation did not show issues related to complaint.All 50 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.Without the device to evaluate, the complaint could not be confirmed, 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 for reports of this nature.

• Brand Name: HOL APPLIER XL 11" RA
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18012226
• Report Number: 3011137372-2023-00234
• Device Sequence Number: 7314524
• Product Code: GDO
• UDI-Device Identifier: 34026704623601
• UDI-Public: 34026704623601
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/12/2023

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: 544192
• Device Lot Number: 06F1871026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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