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

Model Number WB991036

Device Problem Erratic or Intermittent Display (1182)

Patient Problems Pain (1994); Bowel Perforation (2668)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

The subject device was inspected.Externally, the unit is in good condition.Internally, the unit is in good condition.Customer specified fault unconfirmed.When tested, the unit passed all tests in accordance with the oem service manual, the unit was left on soak for test for 6 working days and the customer reported error did not occur.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that during colonoscopy with polypectomy procedure for two (2) patients using this generator, the screen went flickery a couple of times and the noise of cautery sounded wrong.The flickering of the screen coincide with activation of the device.The nursing staff made some check with all connections and found no problem.The procedure was continued and apparently normal.In the first patient, seven polyps were cold snared and two were hot-snared and all seemed alright, the largest polyp was on a distal lip of ileocecal valve about 20 mm, removed en-block and had no apparent concerns.The second patient had extensive diverticulosis and a solitary 12mm lp polyp with a good stalk in distal descending colon.The polyp was snared reasonably well.When trying to retrieve the polyp, found a little cautery burn, a black dot, likely site of perforation.Three metal clips were used to close it.Both patients developed pain in the recovery room.Settings used in patient with pedunculated polyp was force coag effect 2 and w 20.In the cecal polyp normal emr setting slow cut w 120, effect 2 was used.The patient with two polyps removed with hot snare, distal lip of ileocecal valve, had some guarding and rebound in right ileac fossa.The patient with solitary polyp removed had a softer tummy.Both patients transferred to ward, both had computed tomography scan and free peritoneal gas suggesting of perforation.Both patient were good and discharged after few days with conservative treatment.Patient identifiers: (b)(6)- 1st of 2 patients.(b)(6)- 2nd of 2 patients.This report is for (b)(6).

Manufacturer Narrative

The customer was not clear which from two devices (s/n (b)(6) was involved in the event, hence the serial number reported was unknown.The device with serial number (b)(6) was returned and inspected.Externally, the unit is in good condition.Internally, the unit is in good condition.Customer specified fault unconfirmed.When tested, the unit passed all tests in accordance with the oem service manual, the unit was left on soak for test for 6 working days and the customer reported error did not occur.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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 10 years since the subject device was manufactured.Based on the results of the investigation, the customer¿s reported device failures were not confirmed.Therefore, no relationship between the reported medical complications and the reported technical issues could be identified.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device evaluation and the legal manufacturer's final investigation specifically for device serial number (b)(6).Updated field: h10.The device with serial number (b)(6) was returned and inspected.Externally, the device is in a fair condition with no damage or defects detected to the outer casing, but the top cover feels worn and ¿sticky¿.Internally, the device is in a fair condition, but the bind holder on the generator board has become detached and there is a piece of broken plastic on the front panel mask locators.The unit has been inspected and confirmed there is a slight flicker on the right-hand liquid-crystal display when the esg-100 activates the radiofrequency (rf) energy and de-activates the rf energy.Multiple known working boards have been substituted for the customer¿s boards, but the fault persists.Unable to identify the cause of the customer¿s specified fault regarding the flicking display.Unable to confirm the customer¿s specified fault of an abnormal noise.Confirmed the volume control is working correctly with no abnormalities detected with the volume output.The unit passes all output checks, but the device may benefit from a re-calibration.Olympus replaced the control board, display and display cable.The flickering of the display is most likely attributable to a defect of the control board a defect of the display and a defect of the display cable.The perception of sounds is usually subjective.Therefore, olympus cannot definitely determine if the sound was unusual or still normal in this case.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.The risk to patients, users, and/or third parties associated with the reported issues was evaluated as alra (as low as reasonably achievable).In general, the customer is required to check the function of all devices used prior to a procedure.In addition, according to the instruction for use, a suitable replacement device must be provided during an application.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• Type of Device: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16989721
• MDR Text Key: 315844140
• Report Number: 9610773-2023-01414
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K073207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB991036
• Device Catalogue Number: WB991036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male