MAUDE Adverse Event Report: OLYMPUS WINTER IBE GMBH OLYMPUS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	WA22702S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The electrocautery loop was sparking while inside the patient.Once removed from the patient, the loop continued to spark without the foot pedal being depressed.We then turned the machine off.A new plasma loop was opened.The surgeon took the new loop and inserted it into the original white plastic handle of the old loop.There were no further problems.No harm to patient.

• Brand Name: OLYMPUS
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 24568150
• Report Number: 24568150
• Device Sequence Number: 9561746
• Product Code: FAS
• UDI-Device Identifier: 14042761085325
• UDI-Public: (01)14042761085325
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/12/2026
• Report Date (Section F): 01/12/2026

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: WA22702S
• Device Catalogue Number: WA22702S
• Device Lot Number: 1000204687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/12/2026