MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ARGON PLASMA COAGULATION UNIT "APU-300"; WA90004W

Model Number	WA90004W
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the argon plasma coagulation unit was not recognizing the argon gas.The issue occurred during a therapeutic colonoscopy and the procedure was prolonged greater than 30 minutes.There were no reports of patient harm.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2024-01029.This report is related to the following linked patient identifier: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The device was returned to olympus for inspection and the reported failure was confirmed.Testing and investigation revealed a communication problem between the device and the generator.The probable cause was determined to be due to a faulty mother board.Additionally, it was determined that the reported event is an anticipated hazard and this malfunction is not likely to cause or contribute to death or serious injury if the malfunction were to recur.Olympus will continue to monitor field performance for this device.This event was initially conservatively reported as a serious injury due to the procedure allegedly being prolonged by 30 or more minutes; however, there is no evidence the patient suffered any serious injury or adverse effects from the prolonged procedure.Olympus made multiple attempts to receive more information from the customer without success.Thus, correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.

• Brand Name: ARGON PLASMA COAGULATION UNIT "APU-300"
• Common Device Name: WA90004W
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; odakura, nishigo-mura,; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; odakura, nishigo-mura,; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20887959
• Report Number: 3003724334-2024-10022
• Device Sequence Number: 8773448
• Product Code: GEI
• UDI-Device Identifier: 04042761083560
• UDI-Public: 04042761083560
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: WA90004W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROSURGICAL GENERATOR WA90300W
• Patient Sex: Unknown