MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELEKTROCHIRURGIEGERÄT "ESG-150"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	WA90150W
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus that during a colonoscopy, the elektrochirurgiegerät "esg-150" stopped working.As a result, the patient needed to be transferred to the emergency room to have the procedure completed with the same device type from a different procedure room; the procedure was completed successfully.There were no error messages or alarms.It was unclear if a delay occurred, but the colonoscopy lasted 45 minutes due to the issue.The patient sustained a rectal bleed from the polypectomy site, possibly as a result of the device not functioning properly.Despite multiple attempts, interventions and patient outcome was not provided.If additional information is provided, a supplemental report will be sent.

• Brand Name: ELEKTROCHIRURGIEGERÄT "ESG-150"
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, germany 22045 ; GM 22045
• MDR Report Key: 16418037
• Report Number: 2429304-2023-00023
• Device Sequence Number: 16976038
• Product Code: GEI
• UDI-Device Identifier: 04042761085793
• UDI-Public: 04042761085793
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/22/2023
• Report Date (Section F): 01/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA90150W
• Device Catalogue Number: WA90150W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2023
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown