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 Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer reported to olympus that the tip of the thunderbeat 5 mm, 35 cm, front-actuated grip type s broke intra-abdominally during a therapeutic hysterectomy.The issue did not impact the procedure, and it was completed successfully.Additional information was requested but not received.

Event Description

It was additionally reported that the broken piece was retrieved, but the retrieval method was not provided.There was a procedural delay of less than 10 minutes to get a new device, but this did not extend the patient's sedation.The patient's condition was unaffected by the failure and no further medical intervention was required.The procedure was completed with a similar device.It was noted that the device had been inspected prior to use per the instructions for use.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b2, b5, and h6.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: d9, h3, h6 and evaluation results.Lot number (d4) was also corrected.The customer returned a thunderbeat handpiece model number tb-0535fcs lot number kr271606 for evaluation.The device was attached to the usg-400/esg-400 and a probe check was performed; the device failed the probe check; error code u509.Both switches were checked and found both switches are functional.A visual inspection on the received condition was performed on the device; there are large amounts of tissue build up located on the distal end.The ptfe pad (teflon pad) was inspected and found it split in the middle portion of the teflon pad however, no metal is exposed.The distal end of the device was inspected under a microscope and found the probe is detached, the missing portion was returned.The wiper movement is normal.The consistency of movement of the handle and jaw is normal.The handle load is normal.The rotation of the knob torque is normal and smooth.Additional testing was unable to be performed as the probe was broken.The investigaiton is ongoing.A supplemental report will be sent upon completeion.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide a correction to the initial h4.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 the past investigation results, it is likely the probe broke and was recovered occurred due to the following mechanism: 1.The output was activated in seal & cut mode while the grasping section was grasping thick tissue.Therefore, the probe and the tissue pad came into contact at the rear end of the grasping section, causing the tissue pad to wear out.2.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.3.The output in seal & cut was activated while the non-insulated area of the grasping section was in contact with the probe.As a result, a contact mark developed.4.A force to activate the output in seal &cut mode or a force to grasp tissue was applied to the probe.Therefore, cracks developed at a contact mark.5.A force was applied to the probe causing it to break.The event can be prevented by following the instructions for use which state: ¿ 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 tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.¿ when cutting and vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm it is transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation.¿ during the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or twisting the handle.Also, do not insert the handle while the handle is twisted with respect to the tissue, do not grasp it, and do not activate the output.Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad.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: 17798192
• MDR Text Key: 324028499
• Report Number: 9614641-2023-01374
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: KR271606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 09/28/2023; 10/02/2023; 10/10/2023
• Supplement Dates FDA Received: 09/28/2023; 10/05/2023; 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2022
• 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): Required Intervention; Other
• Patient Sex: Female