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

Model Number	OP5669
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned for evaluation.Investigation in progress.A follow-up mdr will be submitted once additional information becomes available.The lot number is unknown, therefore, the applicable production identifiers were not included in the mdr.".
Event or Problem Description
The user facility reported that during a patient procedure their westcott tenotomy scissors were "dull".
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return of the product, the root cause cannot be determined.A 2-year complaint review indicates this to be an isolated event.Steris will continue to monitor for similar events to ensure the product continues to perform as expected.No additional issues have been reported.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.A related report number (h10) was inadvertently included in error by the mdr submitter in the initial report.There is no applicable related report number for mdr number.

• Brand Name: V. MUELLER
• Common Device Name: WESTCOTT TENOTOMY 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: 20314365
• Report Number: 1527821-2024-00014
• Device Sequence Number: 8005144
• Product Code: HNF
• UDI-Device Identifier: 10885403099656
• UDI-Public: (01)10885403099656
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/26/2024

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: OP5669
• Device Catalogue Number: OP5669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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