MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT OPEN FINE JAW; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0009OF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.During device evaluation at olympus, it was found the complaint was confirmed and the grasping section was detached from the insertion section.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported the bipolar jaw of the thunderbeat open fine jaw broke without any reason.The issue occurred during a therapeutic ttl mastectomy procedure.The customer took out a broken tip by grasping it from the patient's body.A similar device was used to complete the procedure.The device was inspected prior to use and no abnormalities were found.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
This report is being supplemented to correct the initial reporting decision from a malfunction only to serious injury and to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The dhr confirmed that the subject device was released in accordance with the specifications.Based on the results of the investigation, the exact cause of the reported event could not be identified.However, based on previous investigation results, it can be inferred that a likely cause of the grasping section detaching from the insertion section might be the following: the grasping section was being left open, and the distal end of the grasping section was pushed against hard material.A load was applied to the distal end of the grasping section.This caused the grasping section to be deformed.An excessive load was applied to the hole where the seesaw pin of the grasping section was inserted due to the deformation of the distal end of the grasping section.As a result, the hole broke.The grasping section detached from the insertion section.The instructions for use (ifu) contains the necessary and enough information to handle the device as follows: should any crack, scratch, deformation, split, protrusion, or partial separating be observed on the probe tip, grasping section, tissue pad, insertion section, 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.When cleaning the grasping section or the probe tip during treatment, wipe it with a soft object such as a piece of gauze or a brush if a body fluid or tissue gets burnt onto it.Do not attempt to scrape it with a hard object such as a scalpel or the tip of tweezers.Otherwise, the grasping section, the metal-exposed area around it, the tissue pad, a coated surface, or the probe tip may be scratched and damaged, which may lead to the damaged part falling off inside the body cavity.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT OPEN FINE JAW
• 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: 17791817
• Report Number: 9614641-2023-01358
• Device Sequence Number: 15298609
• Product Code: GEI
• UDI-Device Identifier: 14953170343343
• UDI-Public: 04953170343346
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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-0009OF
• Device Lot Number: 21K20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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: Prefer Not To Disclose