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 Fracture (1260)

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

Event Date 11/29/2023

Event Type  Injury  

Event Description

A customer reported to olympus, more than an hour after the start of a procedure, while cutting an organ, the tip of the thunderbeat probe came off.The probe fell outside of the patient¿s body.It was recovered within 10 seconds by pinching and collecting utilizing a grasping forceps.Also, an u510 (ultrasonic frequency) error was displayed.The physician stated he did not feel any interference with the metal object.The therapeutic total laparoscopic hysterectomy (tlc) was completed using a similar replacement device.There was a delay of about 30 minutes, because treatment was switched to coagulation using an electrical scalpel.There was no report of medical intervention or patient harm associated with event.

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer in b5.Updated fields: b1,b2,b5,h1,h6.

Event Description

The customer later confirmed the device fell off inside the patient and was recovered immediately.No harm was caused to the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was evaluated by olympus, and the probe was confirmed to be broken.Additional evaluation details are as follows: the probe ruptured 14 mm from the tip.There was a scratch observed around the broken area of the probe, and the breakage was progressing from the scratched area.Also, based on the provided procedure video, it was confirmed that the probe was in close proximity with other equipment.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that reported issue (broken probe) occurred by the following mechanism: 1.The probe encountered hard tissue such as bone or calcified tissue, or with metal clips, stapler needles, or other surgical instruments.2.Due to the stress applied to the probe from sealing, cutting and gripping tissue, the device cracked starting from the scratched area.Additionally, an ultrasonic frequency abnormality (u510) occurred.3.Finally, the probe broke due an applied load.The event can be detected/prevented by following the instructions for use (ifu) 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, other instruments, or 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/split/protruding/partial separating of the tissue pad.In turn, the probe tip 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.¿ this supplemental report includes a correction to d8 to provide information that was inadvertently not included in the previous submissions.Also, an update has been made to h3, and additional information has been added to d9 and h4 from the previous submissions.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: 18323540
• MDR Text Key: 330950501
• Report Number: 9614641-2023-01902
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

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: 36K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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: ESG-400(B001358) ELECTROSURGICAL GENERATOR.; TD-TB400(9924545) TRANSDUCER.; USG-400(9914798)ULTRASONIC GENERATOR.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female