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

Model Number SB-0535FC

Device Problem Fracture (1260)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the subject device probe tip fell off outside of the patient while the power was on, and the probe was getting cleaned.The issue occurred during therapeutic laparoscopic procedure.The intended procedure was completed with another similar device.There were no reports of delays.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d4.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, it is likely occurred the probe was broken by the following mechanism(s): 1) activated output while the probe tip was contacted hard objects such as metal clips, stapler, or other instruments.This caused the probe tip was scratched.2) kept doing activated output in the state described in step ¿1¿.This caused the probe tip was applied a load, cracked due to the scratches on the probe tip.3) some load was applied to the probe and the probe broke.The event can be detected/prevented by following the instructions for use which state: "this product is intended for soft tissues.Do not output with the tip of the probe grasping hard tissues such as bone or calcified tissue, or metal clips, stapler needles, or other surgical equipment (e.G., uterine manipulators or forceps).Scratches on the tip of the probe, heat generated by friction between a hard substance and the tip of the probe can cause severe wear, deformation, tearing, or partial peeling of the tissue pad, and contact between the probe tip and the metal gripping area can cause the probe tip to break before an error message or warning sound is heard.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.Never allow the probe tip to come into contact with or grip metal clips, stapler needles, or other stiff objects of surgical equipment (e.G., uterine manipulators).If the probe tip comes into contact with these hard objects without being noticed, the probe tip may be scratched due to ultrasonic vibration, causing damage or falling off.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.

• Brand Name: SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• Type of Device: 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: 18761488
• MDR Text Key: 336970579
• Report Number: 9614641-2024-00451
• Device Sequence Number: 1
• Product Code: LFL
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SB-0535FC
• Device Lot Number: 37K10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• 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