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

Model Number	RH1650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, a part of the scissors "broke" off onto the patient.It has been reported the broken piece was retrieved successfully.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The scissors subject of the reported event have been returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the event was discarded and could not be returned for evaluation.Without the returned device, a root cause cannot be determined.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: 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: 19821336
• Report Number: 1527821-2024-00006
• Device Sequence Number: 15620975
• Product Code: LRW
• UDI-Device Identifier: 10885403062513
• UDI-Public: (01)10885403062513
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/24/2024

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: RH1650
• Device Catalogue Number: RH1650
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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