MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH: BERLIN OLYMPUS ESG-100, 220...240 V~,; ELECTROSURGICAL SYSTEM GENERATOR

Model Number	WB991036
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001)
Date of Event	05/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that during a polypectomy procedure on a small sessile polyp, the surgeon used saline to raise the polyp and then used g-flex polypectomy snare to snare the polyp.The case was completed without incident.However, the patient returned after two days with abdominal pain.It was later found out there was perforation at the site where the polyp was snared.The surgeon "blames" the nurse assisting him as the nurse reportedly did not set the esg-100 correctly.The patient required laparoscopy to close the perforation.
Event or Problem Description
Additional information was received from the customer.The settings used were pulsecut 40 watts and softcoag 30 watts.The physician recalled they might have stepped on the wrong paddle when snaring and stepped on softcoag instead of pulsecut.There was no allegation of any malfunction against the olympus generator.The patient was currently stable and in good health.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author and to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr), found no deviations that could have caused or contributed to the reported issue.It has been almost 6 years since the subject device was manufactured.Based on the results of the investigation, the root cause of this phenomenon could not be identified.A patient was found to have a perforation after a polypectomy.The reported esg-100 was not returned to olympus for inspection/investigation.There was no report of a malfunction of the device during the procedure.Therefore, the reported device could either be assumed to meet its specification or it could be rated as meeting its specification based on available inspection results.Olympus will continue to monitor the field performance of 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: OLYMPUS ESG-100, 220...240 V~,
• Common Device Name: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH: BERLIN; rheinstrasse 8; telow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH: BERLIN; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17131893
• Report Number: 9610773-2023-01649
• Device Sequence Number: 17764171
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K073207
• 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
• Report Date (Section B): 06/25/2024

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: WB991036
• Device Catalogue Number: WB991036
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 06/25/2024
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/11/2023; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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: G-FLEX SNARE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown