MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 03/16/2023

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A user facility reported to olympus that two days after a laparoscopic colectomy with a thunderbeat 5 mm, 35 cm, front-actuated grip type s, the patient experienced a colon perforation at the site of the ablation.There were no device abnormalities or tissue concerns during the procedure.Additional laparoscopic surgery was performed to treat the perforation.Additional information about the patient outcome has been requested but not received.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b2, b5 and h6.Since the lot number of the subject was unknown, the device history record (dhr) for the past six months prior to the date of occurrence was inspected.No abnormalities were detected in the dhr for the following items which related to the reported phenomenon.- process inspection.- quality inspection sheet.- non-conforming product sheet.The device was not returned, as the product was discarded at the user facility, and the condition of the device could not be confirmed.As a result of checking the instruction manual, the following descriptions related to this event were found.This event (perforation) is included in the instruction manual warnings: use the thunderbeat instrument properly.Improper use may cause the probe tip to fall off inside the body cavity, premature wear, partial separating, deformation, breakage, patient and/or operator injury, malfunction of the cardiac pacemaker, burns of the surgeon, surgical staff and/or patient, electric shock, abnormal output or malfunction, perforation, bleeding, postoperative bleeding, tissue damage and infection to the surgeon, surgical staff and/or patient.Before activating the output, be sure that neither the grasping section nor the probe tip comes into contact with the surrounding tissue.Do not use the thunderbeat if you do not have a sufficient view to confirm the above or if the grasping section and probe tip are penetrating into the tissues.Otherwise, perforation, bleeding, or burns may result.Do not use the thunderbeat if you do not have a sufficient view of the grasping section and probe tip to ensure that only the intended tissue is in contact with the grasping section.The exact cause of the incident couldn¿t be exclusively identified.For the following reasons, it is considered that there was no abnormality in the equipment: ·the surgeon commented that there were no abnormalities of tb-0535fcs in the colectomy, and there were no phenomena of concern about tissue effects.·there were no abnormalities in the manufacturing records.

Event Description

Additional information received indicated that the perforation was discovered at follow up.It was unknown if the patient experienced any signs or symptoms prior to the follow up appointment.It was stated that the patient's hospitalization stay was extended, but the time frame was unknown.The current patient status was reported as "good.".

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• 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: 16732356
• MDR Text Key: 313235186
• Report Number: 9614641-2023-00519
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male