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.This report is related to the following linked patient identifier: (b)(6).
Event or Problem Description
This supplemental report is being submitted to provide a correction to the initial report.No additional information received from customer.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 and b2.B1 should not be marked as an adverse event, and b2 should not be marked at all.The f10 medical device problem reported would not cause or contribute to a death or a serious injury if it were to recur.

• 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
• MDR Report Key: 20887502
• Report Number: 2429304-2024-01029
• Device Sequence Number: 21093241
• Product Code: GEI
• UDI-Device Identifier: 04042761083560
• UDI-Public: 04042761083560
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025
• Report Date (Section F): 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2025
• Device Age: 23 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 04/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROSURGICAL GENERATOR WA90300W.
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/04/2025