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

Model Number	WA90150J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.This report is linked to the following patient identifiers: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a therapeutic endoscopic submucosal dissection a perforation occurred in the stomach.The hole was closed with a paper clip and the procedure was cancelled.The patient is under observation.The doctor did not say it was a device malfunction.The patient was hospitalized and is under observation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide a correction to the initial with information inadvertently left out (b5, e1-email, and g2) and to provide a correction to the initial (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, it is likely use error involving the olympus device could have caused or contributed to the harm in this case.However, the subject device was not returned, and a specific root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the settings for the esg-150 are it knife is pulse cut slow effect 3 40w forced coag, effect 3 25w hemostatic forceps are soft coag effect 4 80w.It was thought by the user that the effect may have been high, and the user ended up talking about lowering the setting by one by one next time.
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: ELECTROSURGICAL GENERATOR "ESG-150"
• Common Device Name: ELECTROSURGICAL 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: 18793733
• Report Number: 9610773-2024-00555
• Device Sequence Number: 7360886
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2024

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/05/2024; 07/15/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/10/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FD-410LR; KD-611L
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown