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

Model Number	TB-0920OE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a robotic total pelvic exenteration (therapeutic procedure), when making the cut the tip had unexpectedly broken off and fell off.Per the report, this caused a short delay (although not clinically relevant) to retrieved the broken piece with another instrument.According to the reporter, the device was inspected prior to use and no issues noted during inspection.The broken piece was retrieved from the patient.The intended procedure was completed with a similar device.There was no patient harm, no adverse impact reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where the reported event was confirmed.The probe was broken at the distal end.There was a mark in the probe which came in contact to the non-insulated area of grasping section and was abraded against it.Also, wear of the tissue pad was observed.The coating of the grasping section was partially peeled off.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, a definitive root cause could not be determined.However based on the device evaluation and the past investigation results, the probe broken and possibly occurred by the following mechanism: 1.Seal & cut¿ output was activated while grasping a thick tissue with the tip of the grasping section.The proximal side of the tissue pad come in contact to the probe.As a result, the pad was worn away.2.The tissue pad was worn away, causing the non-insulated of the grasping section to touch the probe.3.¿seal & cut¿ output was activated under this situation, the scratches indicating that the probe and grasping section were in contact with each other were made.4.The output was continuously activated in state of above description 3, and a force was applied to the probe, causing the probe cracked.5.A load was applied to the probe and it broke.It is possible that the scorched area was scraped by using a hard object.This might have caused the peeling of the coating.The following is included in the instructions for use (ifu): "do not activate output in seal & cut mode while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the ptfe pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating." "when cutting or vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm that they are transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the ptfe pad, or the probe tip may break and fall off, and partial separating of the ptfe pad may occur due to a local increase of temperature caused by the friction between ptfe pad and the probe tip during activation." "do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or positioning the tissue, or twisting the shaft, or rotating the rotation knob.Manipulate and isolate the targeted tissue with another instrument, grasp the targeted tissue with the thunderbeat instrument, and then activate.Otherwise, it may cause the deforming/splitting/protruding of tissue pad or a scratch on the probe tip by interference with the other parts, which could result in the probe tip breaking and falling off inside the body cavity." "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 OPEN EXTENDED JAW
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD; 2-248-1 okkonoki- 1; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15069084
• Report Number: 9614641-2022-00019
• Device Sequence Number: 12187273
• Product Code: GEI
• UDI-Device Identifier: 04953170343315
• UDI-Public: 04953170343315
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TB-0920OE
• Device Lot Number: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSTRUMENT TO RETRIEVED BROKEN PIECE
• Patient Sex: Unknown