MAUDE Adverse Event Report: STERIS DEUTSCHLAND GMBH V. MUELLER; BIPOLAR FORCEPS

Model Number	EBP22150-22S
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices 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 that their bayonet bipolar forceps were "sparking" during insulation testing.No report of injury.
Additional Manufacturer Narrative
The devices subject of the reported event were returned to steris for evaluation.Upon evaluation, it was found that the insulation of the forceps had holes in it.The cause of the reported event is attributed to improper maintenance by a third party.The bayonet bipolar forceps ifu states, "proper care and handling is essential for satisfactory performance of any surgical device.The previous cautions should be taken to ensure long and trouble-free service from all your surgical devices.Inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts.If any of these conditions appear, do not use the device.Return devices to an authorized repair service center, such as steris ims, for repair or replacement." a steris account manager provided in-service training on the proper handling, inspection, and maintenance of the bayonet bipolar forceps.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: BIPOLAR FORCEPS
• 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: 23597081
• Report Number: 3006554912-2025-00002
• Device Sequence Number: 18761415
• Product Code: GEI
• UDI-Device Identifier: 10885403245251
• UDI-Public: (01)10885403245251(10)F25XBI
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/19/2025

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: EBP22150-22S
• Device Catalogue Number: EBP2215022S
• Device Lot Number: (10)F25XBI
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 03/09/2026
• 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