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 Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation/evaluation but to the olympus regional repair center (rrc) in hamburg, germany (returned to the rrc on (b)(6) 2022).During the inspection at the rrc, the reported failure of the cutting function could not be confirmed.Thus, the device was evaluated to meet the standard specifications with regard to this issue.However, the hf-generator was found to permanently display error message e433, which was traced back to a defective generator board.Thus, this issue was attributed to component failure.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 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.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

Event Description

The esg-400 electrosurgical generator was returned to olympus for repair with the customer reporting that the cutting function does not work but the coagulation function does.During inspection at the olympus repair center the device was found to permanently issue error message e433.There is no indication that any of the failures coccured 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 ; 4940669662
• MDR Report Key: 16041003
• MDR Text Key: 308537890
• Report Number: 9610773-2022-00722
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/23/2022

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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• 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