MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 10 CM, INLINE GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0510IC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
Olympus medical systems corp.(omsc)was informed by the customer that during the procedure using the subject device, the following event occurred.The probe was broken off.The customer presumed that it was in contact with the spreading clamps in use on the thyroid gland.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.As a result of checking the device the probe was broken at 17 mm from the distal end.Scratches were discovered in the probe.The crack was widening from the scratched area.There were no scratches or contact marks at the non-insulated area of the grasping section.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.The probe came into contact with a metal object or surgical instruments while the output was activating in seal & cut mode.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 some load.The above device handling has warned in the instruction manual.

• Brand Name: THUNDERBEAT 5 MM, 10 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: 11955958
• Report Number: 8010047-2021-07212
• Device Sequence Number: 14374545
• Product Code: GEI
• UDI-Device Identifier: 04953170308734
• UDI-Public: 04953170308734
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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-0510IC
• Device Lot Number: 09K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1