MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, INLINE GRIP; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535IC

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Type  Injury  

Event Description

It was initially reported that the grasping part of two ultrasonic surgical devices broke off.The mouth was also broken off in the packaging.Consequently, there was a 5-minute delay to the laparoscopic anterior resection surgery to get a new device twice.The customer later clarified that the probe of the other ultrasonic surgical device fell inside the patient and was removed using forceps, which took 1 minute.The same exact issue reportedly happened for the subject device.There was a 10-minute delay to the therapeutic procedure while the patient was under general anesthesia, which was then completed without further incident.There were no reports of patient harm.

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, INLINE GRIP
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19217201
• MDR Text Key: 341456770
• Report Number: 9614641-2024-01018
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170308697
• UDI-Public: 04953170308697
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K111202
• 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: 04/30/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535IC
• Device Lot Number: KR400674
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/30/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention