MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTROSURGICAL GENERATOR "ESG-300"; HF-GENERATORS

Model Number WA90003W

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.Please note: this report is being submitted although the suspect medical device is not marketed in the usa.However, a similar device is marketed.Model # / catalog #: wa90300w; brand name: electrosurgical generator "esg-300"; common device name: hf-generators; 510(k): k180200; product code: gei.

Event Description

Olympus was informed that during a therapeutic colonoscopy/polypectomy procedure, the surgeon felt that the hf generator was not fit for purpose and that it was burning the tissue and not removing the polyp.No further information was provided, but there was no report that a medical intervention of any sort was required.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the evaluation was performed exclusively on the basis of the provided information which did not include the technical condition of the electrosurgical generator.Thus, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, it is assumed that the device met its specification at the time of the reported event and that the insufficient results are due to incorrect device settings.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the electrosurgical generator without showing any abnormalities.The case will be closed on olympus side and the user will be informed about the investigation results.

Event Description

Olympus was informed that during a therapeutic colonoscopy/polypectomy procedure, the surgeon felt that the hf generator was not fit for purpose and that it was burning the tissue and not removing the polyp.However, the procedure was completed successfully with the same device and there was no significant delay.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-300"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11185467
• MDR Text Key: 268695929
• Report Number: 9610773-2021-00048
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA90003W
• Device Catalogue Number: WA90003W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ARGON PLASMA COAGULATION UNIT "APU-300."