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 Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Superficial (First Degree) Burn (2685)

Event Date 12/27/2021

Event Type  Injury  

Event Description

The customer reports during a hysterectomy procedure using a thunderbeat, the patient experienced a 3mm 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.

• 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
• MDR Report Key: 13422729
• MDR Text Key: 284864479
• Report Number: 2951238-2022-00309
• 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: Manufacturer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/04/2022,02/02/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• 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