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

Model Number WB91051C

Device Problem Device Alarm System (1012)

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

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus.No abnormality was found on the appearance or internal part of the device.Troubleshooting was performed after replacing a spare hvps board.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the issue occurred due to a faulty high voltage power supply (hvps) board.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported to olympus that an hf unit had an abnormal sound and error e433 when the machine was turned on.The issue was found during preparation (patients were not anesthetized) before the use of electroscopic surgery.User finished case with another device, and it was not delayed more than 15 minutes.There was no harm or user injury reported due to the event.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16199940
• MDR Text Key: 309066361
• Report Number: 9610773-2023-00263
• Device Sequence Number: 1
• Product Code: FTJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2023

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: WB91051C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• 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