MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, INLINE GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0535IC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus¿s local distributor, but not returned to olympus medical systems corp.(omsc) 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 a laparoscopic radical hysterectomy, the subject device was used.After 20 minutes since the surgery began, the generator showed an error in the probe.When the user checked the subject device, the probe was broken off.The fragment was retrieved from the patient without difficulties.The intended procedure was completed with another device.There was no patient injury reported.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The probe was found to be broken off at 13.5mm from its tip.The broken piece of the probe tip was not returned.There was a mark in the probe which came in contact with the non-insulated area of grasping section and was abraded against it.The broken surface of the probe was checked.It indicated the probe had cracked from the contact mark then broken off.There was a mark in the non-insulated area of grasping section which came in contact with the probe and was abraded against it.The tissue pad in the grasping section was worn away.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.1.The worn of the tissue pad could have happened because "seal & cut" output was activated while grasping nothing with the grasping section and the probe tip, or kept activating the output after a transection of tissue.2.The tissue pad was worn away, causing the non-insulated of the grasping section to touch the probe.3."seal & cut" output was activated under this situation, the scratches indicating that the probe and grasping section were in contact with each other were made.4.The probe received an output load in seal & cut mode or received a load when grasping tissue.As a result, the probe cracked from the scratch and the error occurred.5.The probe broke when added some load to check by customer.The above device handling has warned in the instruction manual.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, INLINE GRIP
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11383399
• Report Number: 8010047-2021-03035
• Device Sequence Number: 3858258
• Product Code: GEI
• UDI-Device Identifier: 04953170308697
• UDI-Public: 04953170308697
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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-0535IC
• Device Lot Number: KR107460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1