MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY 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
Additional Manufacturer Narrative
The device will not be returned for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.This report has been submitted by the importer under this mdr report number 2429304-2023-00303.
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject device was not returned, and a specific root cause of the reported event could not be identified based on the information received.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3003724334.

• Brand Name: ARGON PLASMA COAGULATION UNIT "APU-300"
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17854926
• Report Number: 9610773-2023-02786
• Device Sequence Number: 3278449
• Product Code: GEI
• UDI-Device Identifier: 04042761083560
• UDI-Public: 04042761083560
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 04/29/2024; 07/03/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 04/30/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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: 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