MAUDE Adverse Event Report: STERIS DEUTSCHLAND GMBH V. MUELLER; MAYO DISSECT SCISSORS

Model Number	SA1811
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scissors subject of the reported event are being returned to steris for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported via medwatch report # mw5183262 that during a patient procedure their mayo dissect scissors broke.The procedure was completed successfully using a different device.No report of injury of procedure delay.

• Brand Name: V. MUELLER
• Common Device Name: MAYO DISSECT SCISSORS
• Manufacturer (Section D): STERIS DEUTSCHLAND GMBH; kantstrasse 33/1; wurmlingen, baden-wurttemberg, D-785 73; GM D-78573
• Manufacturer (Section G): STERIS DEUTSCHLAND GMBH; kantstrasse 33/1; wurmlingen, baden-wurttemberg, D-785 73; GM D-78573
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24688748
• Report Number: 3006554912-2026-00003
• Device Sequence Number: 18584516
• Product Code: LRW
• UDI-Device Identifier: 10885403119767
• UDI-Public: (01)10885403119767(10)E21XQS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: SA1811
• Device Catalogue Number: SA1811
• Device Lot Number: (10)E21XQS
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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