MAUDE Adverse Event Report: METZENBAUM SCISSORS; SCISSORS, GENERAL, SURGICAL

Lot Number K20XQS

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

A pair of #5 metz scissors broke at the screw while the surgeon was dissecting tissue in the wound.It was very superficial and all pieces of the instrument were retrieved and sent for inspection.(b)(4).Fda safety report id # (b)(4).

• Brand Name: METZENBAUM SCISSORS
• Type of Device: SCISSORS, GENERAL, SURGICAL
• MDR Report Key: 15371434
• MDR Text Key: 299475864
• Report Number: MW5111900
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: K20XQS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male