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	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus medical systems corp.(omsc) was informed by the physician that during an unspecified procedure using the subject device, the probe was broken off into the patient and an unspecified error occurred.The fragment was retrieved.The intended procedure was completed with another device.There was no patient injury reported.
Additional Manufacturer Narrative
The subject device was returned to olympus (b)(4).However, the subject device was not returned to omsc, because it was a known phenomenon.Therefore, we conducted a survey based on the content of the proposal and the attached photo.It was confirmed that the probe was removed from the attached photo to the complaint information by olympus (b)(4).It is possible to infer the cause from the results of past similar investigations, therefore it was determined that an investigation using equipment with similar structure or similar device is unnecessary.The device history record for the serial number indicated no anomaly with the event-related items below.- [inspection] high-frequency output - [inspection] 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. 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 and the error occurred.The probe broke when added load. 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 and the error occurred.The probe broke when added load.The above device handling has warned in the instruction manual.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12055265
• Report Number: 8010047-2021-07909
• Device Sequence Number: 3503204
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: 0YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose