MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

Model Number UES-40

Device Problem Noise, Audible (3273)

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

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation was unable to duplicate the reported abnormal noise from the device.There were corrosion traces of liquid in the device.The output value of monopole electrocoagulation was low due to defective circuit board, which resulted in display of er02 (short circuit error).The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported that there was alarm when the device worked, and there was louder noise of the fan.The procedure was completed with no reported delay.The fault occurred after use.The customer further reported that the device did not work with alarm when the device was activated.The user did not remember the specific error code, it was said that the error code appeared in the screen when the device worked.It was initially thought that the circuit board was defective.No patient injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the root cause could not be identified because the subject device was not returned to the shirakawa factory, and the phenomenon was not reproduced.However, given that corrosion mark inside the device was confirmed, one of the circuit boards may have malfunctioned causing fan control to not function normally.Also, foreign matter may have entered the fan temporarily.The instructions for use (ifu) states the following: important information ¿ please read before use warning to prevent operator shock and instrument damage, keep liquids away from all electrical equipment.If liquid gets on or into the ues-40, terminate operation immediately and contact olympus.Olympus will continue to monitor field performance of this device.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14503346
• MDR Text Key: 300457491
• Report Number: 8010047-2022-08910
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170287275
• UDI-Public: 04953170287275
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2008
• 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