MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0520FC
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report has not yet been 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
During an open splenectomy, the subject device was used.The device did not seal the vessel.There was no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.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.From the past similar cases, it is assumed that the event occurred due to the following causes.-the user did not squeeze the control handle until it touched the grip handle.-the user stopped the activation in seal mode before sealing was completed and it automatically stopped.-the output level was not appropriate.The instruction manual of the device has already warned as follows; -when treating a blood vessel and/or tissue, squeeze the control handle firmly until the control handle touches the grip handle to stop.Otherwise, incomplete sealing may cause bleeding.-in the seal mode, the lower output setting may cause degradation of seal performance.-during the seal mode, do not stop activation until the ¿seal complete¿ tone is heard.Otherwise, the target tissue may not be coagulated and may bleed.

• Brand Name: THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7741809
• Report Number: 8010047-2018-01507
• Device Sequence Number: 1588250
• Product Code: GEI
• UDI-Device Identifier: 04953170370519
• UDI-Public: 04953170370519
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111202
• 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): 12/21/2018

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: TB-0520FC
• Device Lot Number: 6XK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1