MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0545FCS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus¿s local distributor, but not returned to omsc.Therefore, we conducted a survey based on the content of the proposal and the attached photo.Omsc confirmed that the probe was removed from the attached photo to the complaint information by okr.Omsc confirmed that the probe was removed from the attached photo to the complaint information by okr.The provided information indicates that the product name was tb-0545fcs.The lot no.Was 02k 11.The device history record for the serial number indicated no anomaly with the event-related items below.High-frequency output.Appearance.The exact cause of the event couldn¿t be exclusively identified.However based on the past similar case, the probe broken was possibly occurred due to contact with a surgical instrument or the non-insulated area of grasping section.The detailed mechanisms are shown below.Contact with a surgical instrument during output in seal & cut mode, the probe came in contact with hard tissue, metal or a surgical instrument.Consequently, a scratch was made on the probe.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.The probe broke when added load.Contact with non-insulated area of grasping section the distal end of the tissue pad was worn away because ¿seal & cut¿ output was activated while grasping nothing (including the case the user kept activating after cutting tissue).The tissue pad was worn away, causing the non-insulated of the grasping section to touch the probe.¿seal & cut¿ output was activated under this situation, then the scratches indicating that the probe and grasping section were in contact with each other were made.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.The probe broke when added load.The above device handling has warned in the instruction manual.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from user facility that the probe tip was broken without any reason during the therapeutic procedure,.The user facility took out a broken tip by grasping it from the patient body.The intended procedure was completed with another device.There was no report of patient injury associated with the event.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• 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: 12141258
• Report Number: 8010047-2021-08631
• Device Sequence Number: 17107899
• Product Code: GEI
• UDI-Device Identifier: 04953170383526
• UDI-Public: 04953170383526
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K172610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: Health Professional
• Device Model Number: TB-0545FCS
• Device Lot Number: 02K11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1