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

Model Number	WA90150W
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.This report was submitted by the importer under the importer's report number: 2429304 - 2023 - 00023.
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.
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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, since the device was not returned for an evaluation, the reported issue could not be confirmed.Therefore, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿a suitable replacement device must be provided during an application.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction: d3, g1, h11 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: ELEKTROCHIRURGIEGERÄT "ESG-150"
• 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: 16418059
• Report Number: 9610773-2023-00548
• Device Sequence Number: 19655627
• Product Code: GEI
• UDI-Device Identifier: 04042761085793
• UDI-Public: 04042761085793
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182587
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

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?: 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 07/10/2024
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 06/12/2023; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown