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

Model Number WB91051W

Device Problems Image Display Error/Artifact (1304); Unexpected Shutdown (4019)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The generator was returned to the service center for evaluation.The customer¿s complaint of an ¿e433¿ error message was confirmed due to a faulty generator and printed circuit board.Minor scratches and dings were noted on the generator¿s front panel.The generator passed all other functional test.The dhr review showed, that the device was manufactured according to valid instructions and met all specifications.The cause of the faulty printed board and generator board cannot be determined at this time.The investigation is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed during an unspecified procedure, the generator prompted an ¿e433 footswitch error¿ message.The loops were swapped out and the generator automatically rebooted and the e433 error message reappeared.The customer reported there was no backup footswitch onsite.The intended procedure was completed with different equipment.There was no patient injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The e433 error 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.In this case, error e433 was most likely caused by a defective generator board.Pqi_100-169-441 was issued on error e433 on 28.02.2020.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 (see sbu_100-184-812_en-ds_00 issued on 04.08.2020).

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11440034
• MDR Text Key: 239752665
• Report Number: 9610773-2021-00090
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• 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: B004652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1