MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; SUPERCUT SCISSORS

Model Number	LA8105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices subject of the reported event have been returned to the supplier for evaluation.A follow-up mdr will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during two separate procedures their supercut scissors broke.A short delay was reported in both procedures to swap out the scissors for another pair.The procedures were completed successfully.No report of injury.
Additional Manufacturer Narrative
The devices subject of the reported event were discarded by the user facility and not returned to the supplier for evaluation.Without the returned devices, a root cause of the reported event could not be determined.The device history records were reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A 2-year complaint review indicates this to be an isolated event outside of this user facility.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: SUPERCUT SCISSORS
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 20591617
• Report Number: 1527821-2024-00017
• Device Sequence Number: 15095148
• Product Code: GEI
• UDI-Device Identifier: 10885403052576
• UDI-Public: (01)10885403052576(10)I24VIN
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LA8105
• Device Catalogue Number: LA8105
• Device Lot Number: (10)I24VIN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/02/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown