MAUDE Adverse Event Report: TELEFLEX MEDICAL SUPER-CUT IRIS SCISS. 4 1/2" CVD.; SCISSORS, GENERAL, SURGICAL

Catalog Number	KM35460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from an animal hospital "break at the tip".No patient injury or consequence reported.
Additional Manufacturer Narrative
(b)(4).One sample of (b)(6) lot o2 was received for evaluation.The device received has a broken tip and the general appearance of the device suggests that it has been reprocessed many times.The lot number of the referenced complaint is a7 which is jan 2017 and is separated by 5 years of manufacturing.Both devices were submitted together in from the same event.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.Therefore, a separate complaint history review is not required.Data was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km35460.The observed damage is consistent with tray damage and the 5 year separation of the samples supports this conclusion.However this cannot be confirmed.

• Brand Name: SUPER-CUT IRIS SCISS. 4 1/2" CVD.
• Common Device Name: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19484217
• Report Number: 3011137372-2024-00081
• Device Sequence Number: 12781022
• Product Code: LRW
• UDI-Device Identifier: 24026704263008
• UDI-Public: 24026704263008
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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
• Device Catalogue Number: KM35460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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