MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 35 CM, INLINE GRIP; INSTRUMENT

Model Number	SB-0535IC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that the sonicbeat 5 mm, 35 cm, inline grip broke and fell inside the patient's body during laparoscopic hernia repair.The physician indicated that the device may have possibly twisted.No device remained in the body.The procedure was completed with a similar device without any delay.There was no harm or user injury reported due to the event.The device was inspected prior to use without any issues noted.
Additional Manufacturer Narrative
The suspect device has been returned to olympus, however, an evaluation has not been performed 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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide updates to the initial (d4 lot number and h4).The probable root cause has not changed for this event and the root cause of the phenomenon could not be specified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can be prevented by following the instructions for use which state: "the sonicbeat 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/split/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." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer and the initial device evaluation result.The suspect device was evaluated, and the probe was confirmed to have fallen off.The probe broke 13 millimeters from the tip of the probe.There were scratches around the fracture, and the probe was broken starting from a scratch.There were no scratches on the gripping part.Based on the actual product and past survey results, it was inferred that the reported event occurred by the following mechanism.Hard tissues such as bone or calcified tissue, or metal clips, stapler needles, or other surgeries.Since ultrasonic output was performed when the probe was in contact with the device, scratches occurred in the probe.Since the ultrasonic output was continued in the state of "1", a load was applied to the probe and cracks occurred due to scratches.The probe broke due to some load.
Event or Problem Description
Additional information was received from the customer.The probe broke out of the patient's body and was recovered on the spot.

• Brand Name: SONICBEAT 5 MM, 35 CM, INLINE GRIP
• Common Device Name: INSTRUMENT
• 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: 16964466
• Report Number: 9614641-2023-00702
• Device Sequence Number: 5238439
• Product Code: LFL
• UDI-Device Identifier: 04953170308932
• UDI-Public: 04953170308932
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: SB-0535IC
• Device Lot Number: 2ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 07/18/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/11/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2022
• 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: USG-400
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown