MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-400"; HF-GENERATORS

Model Number WB91051J

Device Problems Connection Problem (2900); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

Olympus was informed that during a transurethral resection in saline (turis) procedure, the electrosurgical generator ¿esg-400¿ displayed error message e006 and could no longer be used.No further information was provided but there was no report about an adverse event or patient injury.

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 #: wb91051w; brand name: electrosurgical generator "esg-400"; common device name: hf-generators; 510(k): k203682; product code: gei.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.Sections d9 and g2 were corrected.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, and since the device was not returned for evaluation, the definitive root cause of the e0006 error message issue could not be determined.It is possible that the e006 error message was caused by an increased resistance between the generator electrodes.The increased resistance may have been caused by tissue build-up on the electrode, poorly or insufficiently placed contacts on the working element or the connection cable, or defective contacts.Olympus will continue to monitor field performance for this device.

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-400"
• Type of Device: HF-GENERATORS
• 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: daniel wladow ; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 15832757
• MDR Text Key: 304002824
• Report Number: 9610773-2022-00549
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051J
• Device Catalogue Number: WB91051J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 03/16/2023; 06/25/2024
• Supplement Dates FDA Received: 04/13/2023; 06/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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