MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT TRANSDUCER

Model Number TD-TB400

Device Problem Communication or Transmission Problem (2896)

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

Event Type  Injury  

Event Description

It was reported that thunderbeat had problems with slow cutting sealing poorly and generator giving constant error messages due to the thunder beat transducer cable in a laparoscopic general surgical procedure (the exact procedure is not known).The procedure was successful, however the procedure took longer due to constant error messages.Follow up information received from the customer indicated that there were 62 error messages in one day predominantly u512 and u504.The cable was reconnected, and the generator restarted.In which 62 error messages occurred that interrupted and delayed the procedure.It was difficult to estimate the procedural delay in minutes, but it took a little over half an hour and at least 30 seconds per error message.The procedure was completed with the same device, and patient was unharmed.Reportedly, loud error messages appeared on the device, ¿causing the user to keep looking at the device to see what the error message and took someone out of their concentration.¿ no pre-existing conditions were known.No reports of patient harm.

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THUNDERBEAT TRANSDUCER
• Type of Device: TRANSDUCER
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19185307
• MDR Text Key: 341115846
• Report Number: 9614641-2024-00989
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170306778
• UDI-Public: 04953170306778
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TD-TB400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other