MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number WB91051W

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected.The reported event could not be duplicated.An intermittent error that is most likely caused by a poor/faulty connection was observed in the error log.The cause cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported the unit produced a high priority error message for a malfunction of the generator during a procedure.The unit would automatically restart during a procedure.

Manufacturer Narrative

This report is being supplemented to provide the legal manufacturer¿s investigation summary regarding this report.According to the customer, the complaint device showed error message e433 during a procedure and restarted automatically.No patient injury was reported.The upon physical evaluation, olympus found the reported error in the error log but was unable to reproduce it during its inspection.Furthermore, olympus found various cases of error e172 in the error log.Upon inspection of the contacts at the lvps, we found traces of dark spots at the contact pins.These traces could be removed with a glass-fiber brush, so they were deposits on the surface of the contact pin.Based on the color, we suspect that these traces are burnt material (contact erosion) generated by an increased electric current over time.The same traces could be found at the contacts of a motherboard, and the contacts of the connecting cable are also likely to be affected.These observations may explain the resistance increase.The lvps connection cable was replaced.The risk to patients, users, and/or third parties associated with all reported issues was evaluated as alra (as low as reasonably achievable).The error messages e433 and e172 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.The customer is basically required to check the function of all devices used prior to a procedure.In addition, according to the ifu, a suitable replacement device must be provided during an application.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10339945
• MDR Text Key: 200879626
• Report Number: 9610773-2020-00172
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K141225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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: WB91051W
• Device Catalogue Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1