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); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus at this time.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported that the lower part of the thunderbeat 5 mm, 35 cm, front-actuated grip type s broke while it was used, in fat, during an unspecified procedure.The fragment was "impossible to find" and if the broken part was made of iron, the patient could not have a magnetic resonance imaging (mri) scan.The practitioner switched to another device.An olympus representative later confirmed that the probe tip is made of titanium alloy.There was no further harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to update the lot number.The suspect device has been returned; however, evaluation has not yet begun.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: the probe was broken at 14.8 mm from the distal end.Scratches were observed around the broken area of the probe.The crack was widening from the scratched area.The distal end of the item was inspected under a microscope and detected no scratches or contact marks at the non-insulated area of the grasping section.The broken piece of the probe tip was not returned.The tissue pad was worn out.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 the past investigation results, it is likely the phenomenon occurred due to the following: during the output activation in seal & cut mode, the probe was contacting hard tissue, metal objects or surgical instruments.Due to ultrasonic vibration, the coating of the probe peeled off.Also, scratches were generated.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.A force was applied to the probe causing it to break.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 of the phenomenon could not be identified.The event can be prevented 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." "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, 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: 17720463
• MDR Text Key: 323086370
• Report Number: 9614641-2023-01301
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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: KR253671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• 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
• Patient Outcome(s): Other