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

Model Number WB91051W

Device Problems Output Problem (3005); Activation Problem (4042)

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

Event Type  malfunction  

Event Description

The esg-400 electrosurgical generator was returned to olympus for repair with the customer reporting that the device does not work.During the inspection at the repair center, error message e433 was found in the error log but could not be reproduced.There is no indication that any of the failures occurred during a procedure and there was no report about an adverse event or patient injurs.

Manufacturer Narrative

The suspect medical device has already been returned to olympus.However, since the evaluation/investigation is still ongoing, the exact cause of the user's experience and the reported phenomenon has not been determined yet.This report will be updated if additional significant information becomes available or once the evaluation/investigation has been completed.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation/evaluation but the olympus regional repair center (rrc) in prerov, czech republic (received at the rrc on 2022-12-19) during the evaluation at the rrc, error messages e433 and e091 were found in the error log but could not be reproduced.Since the error messages could not be reproduced, temporary faults are assumed.However, the exact cause for the occurrence of the error messages could not be determined in this case.Any error messages that may appear during operation are triggered by the safety system of the esg-400 and communicated visually and acoustically to the user.They are part of the device's own security concept.In particularly critical cases, further use of the device is prevented by the security system until the error has been corrected.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the hf-generator without showing any abnormalities.The case will be closed from olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-400"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; rheinstrasse 8; teltow
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; GM ; 4940669662
• MDR Report Key: 16041633
• MDR Text Key: 306794932
• Report Number: 9610773-2022-00726
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2019
• 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