MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"

Model Number WB91051W

Device Problems Defective Component (2292); Electrical Shorting (2926)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject generator was returned to the service center but the evaluation is in process.A review of the generator's history shows the unit was last serviced via repair on (b)(6) 2018.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During preparation for use in an unspecified therapeutic procedure, the high frequency electro-surgical generator displayed error, e433, and has a frayed footswitch.No patient injury or harm was reported.

Manufacturer Narrative

The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The physical evaluation of the device could not duplicate the reported e433 error code issue as the device was inspected, tested and functioned appropriately.Externally, there was cosmetic damage to the external housing and the front panel was missing a screw/washer.The device was repaired and returned to the customer.A review of the device¿s repair history shows the device was last serviced via repair on may 1, 2018 due to intermittent faulty generator (lvps) board.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.A deeper investigation of generator boards with error e433 found a destroyed transformer tr1 to be the cause.An improved generator board was introduced into production in mid-july 2020.Error e433 is activated by the device¿s safety system, which triggers a restart of the device.If the error cause persists, an unlimited number of periodic restarts can be triggered.Possible causes are: the operator activates the footswitch during generator booting (temporary fault caused by user action).A defective footswitch (temporary fault).A defective footswitch (temporary fault, defective reed contact).A faulty cable connection between hvps board and generator board (temporary or permanent fault).A defective hvps board (permanent fault).A defective generator board (permanent fault).As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: a spare generator should be available at all times.Olympus will continue to monitor complaints for this device.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: HF UNIT "ESG-400"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11065106
• MDR Text Key: 227364454
• Report Number: 9610773-2020-00302
• 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: 04/16/2021

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: Other
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Device Lot Number: 12292W130005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1