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
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported from an animal hospital "one pair of the scissors broke with a simple trim of suture ( 3-0 vicrly), and the second was a simple trim of eyelid tissue.Nothing ever noted prior to scissors breaking.Able to finish procedures with other scissors.Both patients recovered without incident." no patient harm or injury reported.
Event or Problem Description
It was reported from an animal hospital "one pair of the scissors broke with a simple trim of suture ( 3-0 vicrly), and the second was a simple trim of eyelid tissue.Nothing ever noted prior to scissors breaking.Able to finish procedures with other scissors.Both patients recovered without incident." no patient harm or injury reported.
Additional Manufacturer Narrative
Qn#(b)(4).Sample of km35460 lot a7 (b)(6) 2017) 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.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to km35460.All complaints are trended across product families on a monthly basis per complaint trending global work instruction.Therefore, a separate complaint history review is not required.The observed damage is consistent with tray damage and the 5 year separation of the samples supports this conclusion.The root cause was undetermined- cannot determine.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19449228
• Report Number: 3011137372-2024-00080
• Device Sequence Number: 8568050
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/19/2024
• 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