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 the exact cause of the reported event could not be conclusively determined at this time.We conducted a survey based on the reported event and the provided photo.From the provided photo, it was confirmed that the probe was broken off.The manufacturing record was reviewed and found no irregularities.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.Based on the past similar cases, it was known that the event occurred due to any of the following possible causes.The probe was cracked when the user activated output contacting with metal or something hard object such as metal clips, stapler, or other instruments, besides the probe was broken off when the probe was subjected to a load.The tissue pad was damaged since the user continued to activate output without grasping tissue (including after the tissue already cut).Also, it was known that the probe was cracked when the user kept activating output of the device with the worn pad, which caused contacting between the probe and the non-insulated area of the grasping section, and besides the probe was broken off when the probe was subjected to a load.The above device handling has warned in the instruction manual.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed by the health professional that during the procedure using the subject device, the probe was broken off.The fragment was retrieved immediately from inside the patient.The intended procedure was completed with another device.There was no patient injury reported.

• 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: 12119910
• Report Number: 8010047-2021-08445
• Device Sequence Number: 3529784
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 02K
• 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: 06/16/2021
• Initial Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1