MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number SB-0545FC

Device Problem Fracture (1260)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation but the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer reported to olympus, during an unspecified therapeutic procedure, an event occurred with the use of 2 sonicbeat scissors.The scissor quickly displayed an error during use on the generator at the start of the operation and while cleaning with a compress at the end, the probe broke.The probe broke outside of the patient¿s body.The coating of the thermos coagulation clamp disintegrated after 3 minutes.The procedure was completed using a replacement device.There was no report of patient harm associated with this event.Related patient identifier: (b)(6).Usage of subject device before event.The usg-400 (ultrasonic generator) software version was 2.00.The setting of itm (intelligent tissue monitoring) ¿on¿ when the sonicbeat was used.In the hospital, the setting of itm is usually ¿on¿ when the sonicbeat was used.The user understood characteristics of itm functionality.The user did not change the itm setting.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for evaluation and the customer¿s allegation of a broken probe was confirmed.Additionally, a partial separation of the tissue pad was recognized.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 that the phenomenon pointed out occurred due to the following mechanism.1.Grasping section was closed without grasping anything while the device was activating in seal & cut mode (this includes after tissue resection) causing the tissue pad to wear out.2.Since the tissue pad was worn out, non-insulated area of the grasping section and the distal end of the probe came into contact.3.The output was activated in seal & cut mode in state of description stated above.Therefore, scratches (contact marks) were made on the distal end of the probe and the grasping section, indicating that they came into contact with each other.4.The device was activated in seal &cut mode or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing this area to have cracks.Also, an error occurred.5.A force was applied to the probe causing it to break.The following are 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, 45 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: 17642587
• MDR Text Key: 322182976
• Report Number: 9614641-2023-01253
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170370571
• UDI-Public: 04953170370571
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SB-0545FC
• Device Lot Number: 2ZK 02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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