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

Catalog Number	137081R
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states prior to use, "customer is having issues with the tip of the appliers and the appliers not grabbing the clip properly.It looks like the jaw is slightly wider in the new appliers just received".Additional information states "one wouldn't pick up the clip as the mouth was too wide and grab it, and the second one bent the clips".No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).One sample of (b)(6) was received for evaluation with lot # 2217601 which predates 2009 manufacturing.This is a refurbished device.Refurbishment date is 05-23 (may 2023) and is due for service.Visual review of the sample noted that the tips are slightly out of alignment.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.All complaints are trended across product families on a monthly basis per (b)(4) complaint trending global work instruction.Therefore, a separate complaint history review is not required.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).Device has far exceeded expected life and is due for service.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
The report states prior to use, "customer is having issues with the tip of the appliers and the appliers not grabbing the clip properly.It looks like the jaw is slightly wider in the new appliers just received".Additional information states "one wouldn't pick up the clip as the mouth was too wide and grab it, and the second one bent the clips".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: 18282220
• Report Number: 3011137372-2023-00255
• Device Sequence Number: 20523481
• Product Code: GDO
• UDI-Device Identifier: 34026704622611
• UDI-Public: 34026704622611
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/20/2023

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 Catalogue Number: 137081R
• Device Lot Number: 2217051
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/31/2024
• 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