MAUDE Adverse Event Report: TELEFLEX MEDICAL HOR TAP ENDO CLIP APPLIER M/L; APPLIER, SURGICAL, CLIP

Catalog Number	338110T
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the clip applicator does not grip the clips, the clips fall out of the clip applicator when put on by the scrub nurse".No patient harm or injury reported.It is additionally stated " the patient did not suffer any injuries during the procedure".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "during visual and functional examination we found the following: the stop for setting the jaw opening is outside the specification, which is why the jaw does not have the correct opening angle to accommodate the clip.The instrument with lot a6-01 was shipped to tfx.Original manufacturing lot is 21545106, dhr review: upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had 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.Normal wear and tear of parts over a longer period of use.At k & 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 " the clip applicator does not grip the clips, the clips fall out of the clip applicator when put on by the scrub nurse".No patient harm or injury reported.It is additionally stated " the patient did not suffer any injuries during the procedure".

• Brand Name: HOR TAP ENDO CLIP APPLIER M/L
• 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: 19226119
• Report Number: 3011137372-2024-00057
• Device Sequence Number: 12842200
• Product Code: GDO
• UDI-Device Identifier: 24026704697100
• UDI-Public: 24026704697100
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: 338110T
• Device Lot Number: A6-01
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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