MAUDE Adverse Event Report: CAREFUSION INC. POTTS TENOTOMY SCISSORS

Model Number	CH5676
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6)has made multiple attempts to contact the user facility to obtain additional information regarding the reported event however, the user facility has not responded.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via medwatch report 3301250000-2023-8022, that during a patient procedure their tenotomy scissor shaft broke in half while the surgeon was using the instrument inside of the patient.No report of injury.
Additional Manufacturer Narrative
Steris made multiple attempts to obtain additional information regarding the reported event however, the user facility has not responded; a root cause could not be determined.A lot number was not provided in medwatch (b)(4).As a lot number was not provided, steris is unable to further perform an investigation.No additional issues have been reported.

• Brand Name: POTTS TENOTOMY SCISSORS
• Common Device Name: TENOTOMY SCISSORS
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19089597
• Report Number: 1423507-2024-01012
• Device Sequence Number: 17917220
• Product Code: DWS
• UDI-Device Identifier: 10885403028779
• UDI-Public: 10885403028779
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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 Model Number: CH5676
• Device Catalogue Number: CH5676
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/18/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown