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 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus, and the evaluation of the reported issue is in progress.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that when removing the instrument from the patient and cleaning it, customer noticed that the tissue pad had completely peeled off.The doctors believed it may have been due to the usg-410-ultrasonic bipolar generator being output for a long time, but not excessively.There was no shedding inside the patient's body.This was succeeding a therapeutic cholecystectomy procedure previously completed using the reported device with no delay.The peeled tissue pad was discarded at the facility, and there was no report of patient harm.

• 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: 18378327
• MDR Text Key: 331367521
• Report Number: 9614641-2023-01970
• 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,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 37K21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2023
• 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: USG-410-ULTRASONIC BIPOLAR GENERATOR