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

Model Number WB91051W

Device Problem Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to olympus for evaluation and repair.The evaluation has not been completed at this time.The investigation is ongoing, and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

It was reported by olympus technician that during maintenance, the hf unit "esg-400 had an error code e433.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.Updates to section h4 and h6.Additionally, a correction to h3 is being made since the device evaluation was not able to be completed.The device history record for the subject device was reviewed and it was verified that the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.Error e433 is triggered by the safety system of the esg-400 and results in a restart of the generator.If the cause of the error remains, there may be an unlimited number of periodic restarts.The following causes are possible: the user activates the foot switch while the generator is booting, a faulty foot switch, a defective cable connection, or a defective circuit board.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

The device was returned for evaluation.The evaluation confirmed the reported e433 error message causing the generators to keep turning off and back on again which was due to a faulty generator board.Additionally, the overlay sticker was missing.The faulty parts were replaced.The device was inspected and passed olympus functional standards.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 12325707
• MDR Text Key: 266722600
• Report Number: 9610773-2021-00228
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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
• Device Lot Number: B006107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1