MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problem Temperature Problem (3022)

Patient Problem Bowel Burn (1756)

Event Date 12/27/2021

Event Type  Injury  

Event Description

The customer reports during a hysterectomy procedure using a thunderbeat, the patient experienced a 3 mm serosal thermal injury, of superficial depth on her bowels, said to be caused by the shaft of the thunderbeat.Although the burn appeared quite superficial, the physician thought it prudent to repair it by over sewing the bowel.There were no additional consequences to the patient reported.The generator settings used in the procedure were reported as "it is understood that the settings are automatic when the device is plugged into the tower." there was no known malfunction of the generator.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This reported event has been reported by (b)(4).

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported.Physical evaluation of the suspect device: the device was attached to the usg-400/esg-400 and a probe check was performed; the device passed the probe check.Both switches were checked and found both switches are functional.A visual inspection on the received condition was performed on the device; there is some tissue build up located near the distal end of the shaft as well as on the jaw.The ptfe pad (teflon pad) was inspected and found it has normal wear, no metal exposed however there are signs of dried foreign residue.The distal end of the device was inspected under a microscope and found no visual indication of damage to the probe unit.The wiper movement is normal.The consistency of movement of the handle and jaw is normal.The handle load is normal.The rotation of the knob torque is normal and smooth.Olympus observed the distal end of the shaft and identified dried foreign residue.Additionally, the technician grasped a wet cotton pad soaked with saline with the distal end of the device.Mq activated the purple seal & cut switch and observed vapors of moistures with no error codes indicating seal & cut switch was working as intended.Mq then activated the blue seal switch and again observed vapors of moistures with no error codes indicating the blue seal switch was working properly.The device history record (dhr) for the suspect device was reviewed.It was confirmed that the device met all design and safety requirements when it was shipped.The instructions for use (ifu) shipped with the device provides the following instructions related to the reported event: ¿ to seal adjacent tissue, overlap the edge of the existing seal.The second seal should be distal to the first seal to increase seal margin.Otherwise, incomplete sealing may cause bleeding and/or the existing seal may be opened.¿ the grasping section and probe tip become hot due to extended ultrasonic output.Do not let it come in contact with tissues other than the target tissue.Conclusion summary; the exact cause of the event couldn't be conclusively identified.However based on the investigation results and past investigation results, it is possible that the device became hot immediately right after output activation.This device might have touched the tissue, causing the reported phenomenon.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13422738
• MDR Text Key: 284862050
• Report Number: 8010047-2022-02284
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: UNKNOWN
• 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: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: GENERATOR, SN (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 50 KG