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

Model Number	USG-400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
We received the following report: during an extensive hysterectomy plus pelvic lymph node dissection, the subject device was used.The operation panel display of the device disappeared and the device restarted automatically.The physician stopped using the device immediately, then, completed the procedure with a similar medical device.Bleeding increased during this procedure.There was no patient injury reported.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.No detailed information could be obtained on the failure occurrence.According to the local staff, the subject device showed no anomalies when inspected by the third party.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.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases and the check results of the subject device by the local service center, possible causes of the rebooting are shown below.Power supply noise or a decreased power supply voltage caused a temporary control failure to the device.Inappropriate connection of the power cable with the generator caused a temporary control failure to the device.The above device handling has warned in the instruction manual as follows.If any irregularity is observed during the use of the ultrasonic generator, immediately stop using it and take proper measures by referring to chapter 8, ¿troubleshooting¿.Also, refer to the instruction manual for the thunderbeat and/or sonicbeat instrument in use.If the irregularity cannot be resolved, contact olympus.

• 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: 9514233
• Report Number: 8010047-2019-04549
• Device Sequence Number: 2650960
• Product Code: LFL
• UDI-Device Identifier: 04953170306754
• UDI-Public: 04953170306754
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: Health Professional
• Device Model Number: USG-400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR