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	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that during polypectomy procedure using this generator and non-olympus snare, they placed clip on the polyp to stop the blood flow.The procedure was completed as planned.The patient developed melena after returning home.The patient was examined at another facility and no other health damage was confirmed thereafter.It was unknown what examination was performed.There were no reports of further patient or user harm associated with this event.
Additional Manufacturer Narrative
E1 establishment name: (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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer.Updated fields: b2, b5, h6.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
Olympus further received information that the patient received iv treatment at another hospital, and the melena stopped.The subject device was not inspected prior to use.The setting mode and output value were: pulse cut first effect (1) 10w, forced coag effect (3) 30w.
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 e1, e2, e3 and to provide an update to 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.
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 (b)(4).

• 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: 17995701
• Report Number: 9610773-2023-03048
• Device Sequence Number: 17600016
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2024

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: 10/25/2023; 03/06/2024; 07/11/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/16/2023; 03/08/2024; 07/11/2024
• 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; Hospitalization
• Patient Sex: Male