MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELEKTROCHIRURGIEGERÄT "ESG-150"; ELECTROSURGICAL SYSTEM GENERATOR

Model Number	WA90150J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Melena (4480)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 establishment name: department of gastroenterology, (b)(6) medical corporation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that during polypectomy procedure using this generator and non-olympus snare, they performed local injection without using a clip to remove the polyp.After that, the bleeding was stopped with a hemostatic clip.The procedure was completed as planned.The patient developed melena after returning home.The patient was examined and underwent an endoscopy at a later date.It has been confirmed that the excision site clip is attached.No other health damage was confirmed.There were no reports of further patient or user harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out g2.Additionally, to provide a correction to the initial a3, e1, e2, e3 and to provide an update to b5 and h4.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 relationship between the device and the adverse events cannot be confirmed.Furthermore, the subject device was not returned, and a root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information received: the subject device was not inspected.The setting mode and output value are as follows: pulse cut first effect 10w and forced core effect 30w.After the polypectomy, bleeding did not stop, therefore a clip and ligature were used to stop the bleeding, and the patient was transported to another hospital for hospitalization and observation.After that, the patient was discharged from the hospital after confirming that there was no bleeding.
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 SYSTEM GENERATOR
• 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: 17995792
• Report Number: 9610773-2023-03049
• Device Sequence Number: 6753630
• Product Code: GEI
• UDI-Device Identifier: 04042761085793
• UDI-Public: 04042761085793
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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: WA90150J
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 03/06/2024; 07/03/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 03/07/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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: BOSTON MADE 27MM SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male