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

Model Number	OP5525
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that their vital knapp iris scissors broke at the tip during a procedure.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.A microfracture was observed in the scissors; however, an exact cause of the reported event could not be determined.The vital knapp iris scissors ifu states, "prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage." the device history record was reviewed and it was confirmed the device was manufactured to specifications; no abnormalities were noted.A 2-year complaint review confirmed this to be an isolated event.No additional issues have been reported.
Additional Manufacturer Narrative
In the previous follow-up report, "combination product" was inadvertently selected in error by the report submitter.The device subject of the reported event is not a combination product.

• Brand Name: V. MUELLER
• Common Device Name: VITAL KNAPP IRIS SCISSORS
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 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: 20798306
• Report Number: 1527821-2024-00023
• Device Sequence Number: 7809755
• Product Code: HNF
• UDI-Device Identifier: 10885403063107
• UDI-Public: (01)10885403063107(10)I21XMR
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2024

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
• Operator of Device: Health Professional
• Device Model Number: OP5525
• Device Catalogue Number: OP5525
• Device Lot Number: (10)I21XMR
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/12/2025; 03/14/2025
• 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