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

Model Number	IPN013164
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the tip broke off during surgery.There was no patient harm or injury.
Event or Problem Description
It was reported that the tip broke off during surgery.There was no patient harm or injury.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the tip broke off during surgery.There was no patient harm or injury.
Additional Manufacturer Narrative
Qn # (b)(4).The sample was returned for investigation.It was found that the device had a broken tip.The fracture appears approximately 3mm behind the distal tip of the outside curved blade.There were no issues found pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to this product code (km35460).Based on the investigation performed, it was determined that the broken tip is not related to manufacturing and is consistent with tray damage or a dropped instrument.Other remarks: n/a corrected data: n/a.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16683460
• Report Number: 3011137372-2023-00070
• Device Sequence Number: 7387307
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2023

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 Model Number: IPN013164
• Device Catalogue Number: KM35460
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 05/23/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/10/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown