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

Model Number SB-0535FC

Device Problem Peeled/Delaminated (1454)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the sonicbeat 5 mm, 35 cm, front-actuated grip tissue pad came loose.The issue occurred during a therapeutic laparoscopic cholecystectomy.The pad did not fall off in the patient and the procedure was completed with a similar device.There was no delay to the procedure and no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction to d4 and g2 (inadvertently selected healthcare professional).The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.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 possible that the tissue pad was worn out and part of it came off because the ultrasound was output with the gripper closed without gripping the tissue (including after the tissue was cut).The event can be detected/prevented by following the instructions for use which state: "do not activate output 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 or vessel sealing is performed, 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 tissue pad, or the probe tip may break and fall, 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".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: 18253411
• MDR Text Key: 330021250
• Report Number: 9614641-2023-01830
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170370540
• UDI-Public: 04953170370540
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2023
• 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: 36K02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• 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: TD-SB400 SONICBEAT TRANSDUCER.; USG-400 ULTRASONIC GENERATOR.