MAUDE Adverse Event Report: CAREFUSION INC. POTTS TENOTOMY SCISSORS

Model Number CH5676

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2023

Event Type  malfunction  

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 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.

• Brand Name: POTTS TENOTOMY SCISSORS
• Type of Device: 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
• MDR Text Key: 339990933
• Report Number: 1423507-2024-01012
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10885403028779
• UDI-Public: 10885403028779
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: CH5676
• Device Catalogue Number: CH5676
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1