MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. 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	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has been returned for evaluation but has not yet begun.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that during therapeutic laparoscopic surgery, one of the two probes of this ultrasonic surgical device, broke and fell into the patient's abdomen.The generator went into alarm because the forceps could no longer function.The piece was immediately recovered and the clamp isolated.Additional information received that the operating mode was coagulation.The procedure was completed with a similar device.No procedure delay.There were no reports of further patient or user harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and evaluation with correction to the initial with information inadvertently left out.Additionally, to provide an update to field h3.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The evaluation results are as followed: the breakage started at the cracked area of the probe, the coating of the grasping section was partially peeled off, and tissue pad wear.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the error and the probe broken possibly occurred by the following mechanism: 1) during the output activation in seal & cut mode, the distal end of the probe was slightly contacting a device with a thin tip, causing spark generation.2) a force was applied to the probe during spark generation.3) a force to grasp tissue or a force to activate the output in seal & cut mode was applied to the probe.This generated cracks on the probe causing an error.4) due to continuous use of the device, the cracks on the probe progressed.This led to breakage of the probe.The coating of the grasping section could have come off when dirt such as burn was scraped off with something hard.However, the root cause could not be identified.The event can be prevented by following the instructions for use which state: ¿ do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.In addition, the high-frequency (rf bipolar) current flows through the metal and generates spark discharge, which may cause burns and decrease functionalities.¿ if the grasping section, metal-exposed area around it or the probe tip gets sticked tissue during treatment, wipe it with a soft object such as a piece of gauze or a brush.Do not attempt to scrape it with a sharp object such as a scalpel or the tip of tweezers.Otherwise, the grasping section, metal-exposed area around it, the fluorine resin part, a coated surface or the probe tip may be scratched and damaged, which may lead to fall-off of the damaged part into the body cavity or burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• 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
• 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: 17100908
• Report Number: 9614641-2023-00830
• Device Sequence Number: 19328615
• Product Code: GEI
• UDI-Device Identifier: 04953170383526
• UDI-Public: 04953170383526
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: TB-0545FCS
• Device Lot Number: KR292837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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