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

Model Number WB91051W

Device Problem Circuit Failure (1089)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

Olympus was informed that outside a procedure during routine inspection the esg-400 hf-generator issued error code e090 and restarted itself.Since the error occurred outside a procedure no patient was involved and there was no 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.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation but to an olympus regional repair center (rrc) in india (returned to rrc on 2022-09-22).Even though the evaluation could not reproduce the occurrence of error message e090, it was shown in the hf generator¿s error log.Error message e090 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, error message e214 was found which as well is triggered by the generator¿s safety system.In the case at hand, this was traced back to a defective motherboard.Thus, this phenomenon can be attributed to component failure.Also, the evaluation found several components of the device to be corroded, the powder-coating of the top cover to be rusty and partly peeled off and the top cover to be scratched.The cause for these findings is very likely improper handling by the user.However, they are not related to the described error messages.Furthermore, 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.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-400"
• Type of Device: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg ; GM
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; rheinstrasse 8; teltow
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15500374
• MDR Text Key: 306366052
• Report Number: 9610773-2022-00448
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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