MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER SMALL 8" CVD; APPLIER, SURGICAL, CLIP

Catalog Number	137081
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the jaws were found misaligned when the applier was checked after cleaning after use".No patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer for investigation.The manufacture reported: "per customer provided information, we are unable to perform a dhr review for the alleged defective instrument, lot information has not been provided and this instrument has not been returned for review or evaluation as it has been discarded at the end user's facility.We are unable to validate the alleged complaint for this device.All instruments of this type are 100% visually inspected 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 reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the jaws were found misaligned when the applier was checked after cleaning after use".No patient involvement.

• Brand Name: HZ APPLIER SMALL 8" CVD
• 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: 18536329
• Report Number: 3005236665-2024-00001
• Device Sequence Number: 17825586
• Product Code: GDO
• UDI-Device Identifier: 34026704622611
• UDI-Public: 34026704622611
• 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): 01/12/2024

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: 137081
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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