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 Device Remains Activated (1525)

Patient Problems Abdominal Pain (1685); Unspecified Kidney or Urinary Problem (4503); Unspecified Tissue Injury (4559)

Event Date 09/26/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a laparoscopic with bilateral salpingectomies procedure wherein a thunderbeat device was used.The physician stated in his operative note that "bladder adherent to the anterior lower uterine segment.Both ovaries adherent to the uterus and large bowel.Left ovarian cyst.Both fallopian tubes enlarged and adherent to anterior abdominal wall and adnexa.On postoperative cystoscopy, there was efflux of urine from both ureters with intact bladder mucosa." in the description of the operation, there was no mention of identifying the path of the ureter in the operative field.Despite complaints of continued pain following the surgery, the patient was discharged.On october 8, 2022, the patient was evaluated in the user facility's emergency department because of "intermittent abdominal pain since the procedure." she presented with worsening suprapubic and left lower quadrant abdominal pain that has been getting worse and is constant now.On october 9, 2022, the patient had a urology consult and it was concluded that there was a concern for injury either to the bladder and/or ureter.On october 10, 2022, the patient underwent a cystoscopy to evaluate her bladder and ureters for possible injury or leak.The patient was told she would need a repair of the ureter and possibly a ureteral implant.On october 10, 2022, the patient had a left nephrostomy tube placement.The patient presented to another facility on january 12, 2023.Gynecology and oncology was consulted due to her recurrent abdominal pain.She was then evaluated and offered definitive surgery to repair her left ureter and resect her persistent abdominal mass.On (b)(6) 2023, she underwent a left salpingo-oophorectomy, left ureteroneocystostomy with double j stent placement and omental flap.On (b)(6) 2023, she was discharged home with a ureteral stent.On (b)(6) 2023, the ureteral stent was removed.It was further reported that the thunderbeat device was defective because the seal button would remain engaged after the button is released and not immediately return to a neutral position.This left the seal action engaged to prolong the burning effect and left the other organs and the patient exposed to unintended thermal injuries.The device which burned when the doctor did not realize it was burning, allegedly caused the thermal injury to the patient.The patient allegedly suffered extreme pain and agony which continues to the present and which is expected to continue for the rest of her life.

• 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
• MDR Report Key: 18587629
• MDR Text Key: 333847563
• Report Number: 2429304-2024-00080
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2024,01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female