MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number	SB-0535FC
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	10/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy, the probe tip broke and fell into the patient's abdominal cavity and was removed immediately by the medical staff using forceps.This created a 2 minute delay.The device was inspected prior to use and there was no abnormality noted.The procedure was completed with a back up (same) device without delay or patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) investigation.The device was evaluated by olympus, and the gripping section of the device was confirmed to be fractured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the detachment of the grasping section of the device was likely due to the following: 1.An excessive force (in the direction for opening) was applied to the grasping section.This caused the grasping section to detach from the shaft.2.Since a force (in the twist direction) was applied to the detached grasping section, the distal end of the inner pipe broke.As a result, the grasping section fell off.However, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿when inserting the thunderbeat into or withdrawing it from the trocar tube, gently hold the control handle and make sure that the grasping section is closed.If the thunderbeat is inserted or withdrawn with the grasping section open, the probe tip/grasping section may become damaged, or it may become impossible to withdraw it from the trocar.¿ ¿should any crack, scratch, deformation, split, protrusion, or partial separating be observed on the probe tip, grasping section, tissue pad, shaft, the surface of the transducer, transducer cord, or transducer plug, do not use them and replace the damaged instrument or the transducer with a spare.Using a damaged device may cause burns due to abnormal output or high-frequency (rf bipolar) current leakage or breakage of the probe tip, the tissue pad, and the grasping section.¿ this supplemental report includes an update to h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's updated investigation.Based on the results of the updated investigation, it is likely that the reported event occurred due to the following mechanisms: 1.Excessive load was applied to the grip part in the direction of opening, causing the fulcrum pin to deform and the grip part to come off from the insertion part.2.With the grip part detached, the jaw rear pin came loose, causing the grip part to fall off.Additionally, the gripping part was not returned, and it was not possible to determine what caused the jaw rear pin to come off.Therefore, the specific root cause of the reported event could not be determined.

• Brand Name: SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20636765
• Report Number: 9614641-2024-02074
• Device Sequence Number: 7367577
• Product Code: LFL
• UDI-Device Identifier: 04953170370540
• UDI-Public: 04953170370540
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K211838
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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 Number: SB-0535FC
• Device Lot Number: 41K26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 03/04/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/03/2024; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown