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 11/22/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, after approximately two hours of using the device in a therapeutic laparoscopic inguinal hernia repair procedure, the device tissue pad peeled.The procedure was completed by switching to a new similar device.There was no delay to the completion of the procedure.The patient did not need additional anesthesia.There is no harm or adverse impact to the patient.A u504 probe damage error was received for the device.The intelligent tissue monitoring (itm) setting was on during the procedure.The device was inspected prior to use with no anomaly noted.The connections to the generator were checked.The transducer cords and other medical device cords are not bundled together.

Manufacturer Narrative

The device is returned, and an evaluation completed for it.The user¿s complaint was confirmed.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Upon inspection and testing, it was observed that the tissue pad was worn out and partially peeled off.The probe had contact marks which indicated that the probe and the grasping section came into contact.The grasping section had contact marks which indicated that the probe and the grasping section came into contact.Root cause for the event could not be conclusively determined.A likely cause the reported event might be the following: grasping section was closed without grasping anything (this includes after tissue resection) while the ultrasonic output was activated.This caused the tissue pad to wear out and partially peeled off.Since the tissue pad was peeled off, the grasping section and the probe came into contact.The ultrasonic output was activated while the grasping section was contacting the probe causing an error(probe damage error u504).Also, this caused the probe to have contact marks.The instructions for use includes the following statements that warn against the issue: ·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.

Manufacturer Narrative

Correction being made to the lot number.This supplemental report is being submitted to provide this information.

• 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: 15973724
• MDR Text Key: 308561948
• Report Number: 9614641-2022-00759
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 14953170370547
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 27K 19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• 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-SB400ESG-400USG-400