MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SINGLE USE PLASMA COAGULATION PROBE "AXIAL ARGON PA-211U", 2.3 X 2200 MM

Model Number	WA94002A
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the plasma coagulation probe output did not start when attempting to stop bleeding.The issue occurred during an unspecified procedure.The procedure was completed after switching to the same product.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction: d9.Additional information: d8, h3, h6, h11.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, there were no indications of a malfunction; therefore, a root cause for the reported event was not determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE PLASMA COAGULATION PROBE "AXIAL ARGON PA-211U", 2.3 X 2200 MM
• Common Device Name: PLASMA COAGULATION PROBE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20236966
• Report Number: 9610773-2024-02241
• Device Sequence Number: 20873717
• Product Code: GEI
• UDI-Device Identifier: 14042761083420
• UDI-Public: 14042761083420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: WA94002A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown