MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR

Model Number	USG-400
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During an excision of carotid body tumor, the subject device was used.The subject device made alarm and rebooted itself three times.There was another available device.There was no patient injury reported.This is the report regarding the exchange of the generator.
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Omsc received the additional information that esg communication error had occurred.Omsc also received the additional information that there was no abnormality when the subject device was inspected by olympus local engineer of keymed.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases and the information, omsc assumes that the event occurred due to any of the following possible causes.Power supply noise and a decreased power supply voltage caused a temporary control failure to the usg-400.Inappropriate connection of the power cable with the generator caused a temporary control failure to the usg-400.The above device handling has warned in the instruction manual as follows.*should any irregularity be observed, do not use the ultrasonic generator and take proper measures by referring to chapter 8, ¿troubleshooting¿.If the irregularity is still not resolved, do not use the ultrasonic generator and contact olympus.Using irregular instrument may cause a malfunction and may also result in an electric shock, burns, and/or fire hazard.

• Brand Name: ULTRASONIC GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9567600
• Report Number: 8010047-2020-00847
• Device Sequence Number: 19680462
• Product Code: LFL
• UDI-Device Identifier: 04953170306754
• UDI-Public: 04953170306754
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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
• Operator of Device: No Information
• Device Model Number: USG-400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1