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 Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report has not yet been returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During a total laparoscopic hysterectomy, the subject device was used.The probe of the subject device broke off and fell inside the patient body.The fragment was retrieved.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the breakage of the probe.
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.The probe was broken off at 16 mm from the distal end.The broken fragment of the probe was not returned.The probe had a mark contacted with the grasping section.The fracture surface of the probe showed that crack developed.The proximal side of the tissue pad was worn.The grasping section had a mark contacted with the probe.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the tissue pad at the proximal side was damaged since the user activated output while the subject device was grasping a thick and hard tissue.It was also known that the proximal side of the grasping section and the probe came into contact since the tissue pad at the proximal side was damaged, consequently the probe cracked, 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 as follows.During the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue or twisting the handle.Also, do not activate the output, while torque is applied to tissue over the handle, in this instance release the torque, re-grasp the tissue and re-activate output.Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad.Do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator, forceps, and others).Otherwise, it may cause the probe tip to be scratched or come into direct contact with the metal area of the grasping section as the heat generated by the friction between the hard object and the probe tip could cause wear/deforming/splitting/protruding/partial separating of the tissue pad.In turn, the probe may break before displaying an error window or generating an alarm tone.

• 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
• MDR Report Key: 8626992
• Report Number: 8010047-2019-01982
• Device Sequence Number: 14017317
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: 85K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1