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

Model Number WB91051C

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

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus shanghai (osh)/china (returned to osh on (b)(6) 2022).Even though the evaluation could not reproduce the occurrence of error message e433, it was shown in the hf generator¿s error log.Error message e433 is triggered by the generator¿s safety system and can have different technical causes.In case of critical errors, the safety system will not permit any further use of the generator until the error is rectified.In the case at hand, the error message could not be reproduced.Thus, a temporary fault is assumed and the exact cause for the occurrence of the error message could not be determined in this case.In addition, the relay board and the front panel were found to be not correctly fixed.This was most likely caused by either an improperly performed service activity or an unauthorized third-party manipulation.However, these defects are not related to the occurrence of the reported error message.Also, 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 on olympus side with no further actions, but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.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.

Event Description

A loaner electrosurgical generator "esg-400" was returned to olympus for repair reportedly showing error message e433.There is no indication that the reported failure occurred during a procedure and there was no report about an adverse event or patient injury.

• 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 14513 ; GM 14513
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 16058603
• MDR Text Key: 308526852
• Report Number: 9610773-2022-00758
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/28/2022

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: WB91051C
• Device Catalogue Number: WB91051C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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