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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP; ULTRASONIC SURGICAL DEVICE
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AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP; ULTRASONIC SURGICAL DEVICE Back to Search Results
Model Number TB-0535PC
Medical Device Problem Codes Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/24/2025
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the tip of the subject device broke off and was retrieved from the patient during a therapeutic total laparoscopic hysterectomy procedure.The procedure was completed with a back-up device.There were no reports of patient harm.
 
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Brand Name
THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP
Common Device Name
ULTRASONIC SURGICAL DEVICE
Manufacturer (Section D)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA  036-0357
MDR Report Key21868180
Report Number2429304-2025-00135
Device Sequence Number7888667
Product Code GEI
UDI-Device Identifier04953170308659
UDI-Public04953170308659
Combination Product (Y/N)N
Initial Reporter StateKY
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/18/2025
Report Date (Section F) 04/18/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberTB-0535PC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2025
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/24/2025
Event Location Hospital
Date Report to Manufacturer03/24/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/18/2025
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
Date Report Sent to FDA04/18/2025
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