MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ARGON PLASMA COAGULATION UNIT "APU-300"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	WA90004W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Burn(s) (1757); Hemorrhage/Blood Loss/Bleeding (1888); Nausea (1970); Septic Shock (2068); Vomiting (2144)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that when using an argon plasma coagulation unit ¿apu-300¿, the patient experienced a rectal burn.The device was turned on and there were no failure or error messages displayed at that time.The event occurred during the therapeutic procedure (colonoscopy with polyps removal).The settings for the esg were 120 and 4.A non-olympus hot snare was used during the procedure.The procedure was completed with the same device.The patient was hospitalized for several days post-procedure due to acute abdominal pain and rectal bleeding with nausea and vomiting.Ct scan showed some inflammatory colitis with mural edema suggesting proctitis secondary to colonoscopy with two polypectomies ¿ a large polyp in the rectum and small polyp in sigmoid.A flexible sigmoidoscopy was performed revealing a 2 x 2.5 cm ulcer 4 cm from the dentate line and proctitis.The patient subsequentially went into septic shock and was admitted to the icu on vasopressors.The patient eventually was discharged home and was to follow-up with his pcp, gastroenterology, and infectious disease.

• Brand Name: ARGON PLASMA COAGULATION UNIT "APU-300"
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 17854370
• Report Number: 2429304-2023-00303
• Device Sequence Number: 3453394
• Product Code: GEI
• UDI-Device Identifier: 04042761083560
• UDI-Public: 04042761083560
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2023
• Report Date (Section F): 09/05/2023

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: 09/05/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A NON-OLYMPUS SNARE; CF-HQ190L EVIS EXERA LLL COLONOVIDEOSCOPE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American