MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Event Description

A customer reported to olympus, during surgery, the thunderbeat had an instrument malfunction and a broken jaw.The hysterectomy was completed using a replacement device.There was no report of patient harm associated with this event.Usage of subject device: the usg-400 (ultrasonic generator) software version was 2.00.The setting of itm (intelligent tissue monitoring) ¿on¿ when the thunderbeat was used.In the hospital, the setting of itm is usually ¿on¿ when the thunderbeat was used.The user understood characteristics of itm functionality.The user did not change the itm setting during the procedure.The device was in use for 30 minutes prior to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide corrections and additional information obtained from the customer regarding the reported event.New information added to the following fields: b1, b2, b5, d8, d9, d10, h1, h3, h6 (component code, health effect impact code, health effect clinical code).Corrected fields: d8, medical device component code.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer additionally reported that an error titled "ultrasonic level error".Displayed on the usg-400; after a minute, it then displayed a "probe damage error." the tip of the device fell into the patients body and was extracted by the surgeon.It was noted that the device had been inspected prior to use and no abnormalities were detected.

Event Description

It was reported the surgery was successfully completed and the patient was under general anesthesia.It took less than 10 seconds to retrieve the tip fragment.The patient is well and enjoying normal daily activities.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, correction to the initial with information inadvertently left out (g2), to provide additional information received (b5), and to provide an update to fields (d4-lot number, h3, and h4).The device was evaluated by olympus and it was confirmed the probe was broken at 14 mm from the distal end.Additionally, the broken piece of the probe tip was not returned and there were non-reportable (non-pae) defects noted.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 and past investigation results, it is likely that the broken of the probe and the errors could be due to the following mechanisms.1) during the output activation in seal & cut mode, the probe was contacting hard tissue, metal objects or surgical instruments.2) due to ultrasonic vibration, the coating of the probe peeled off.Also, scratches were generated.3) a force to activate the output in seal & cut mode, or a force to grasp the tissue was applied to the probe.Therefore, cracks were generated at the scratched area, the ultrasonic level error, and the probe damage error occurred.4) a force was applied to the probe causing it to break.However, a specific root cause of the reported event could not be identified.The event can be detected by following the instructions for use which state: "the thunderbeat instrument should be used for soft tissue.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." "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." olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: 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: 18323701
• MDR Text Key: 330953294
• Report Number: 9614641-2023-01903
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: KR345661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: USG-400 - SERIAL (B)(6)
• Patient Outcome(s): Required Intervention