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 Break (1069)

Patient Problem Bowel Perforation (2668)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned for evaluation.If additional information becomes available following device evaluation, a supplemental report will be filed.

Event Description

The company representative reported that during a laparoscopic supracervical hysterectomy the tip of the thunderbbeat broke and fell inside the patient.The clinician was able to retrieve the broken piece.This event happened toward the end of the procedure and the procedure was completed.It was unable to be determined if the user replaced the item with another item to complete the procedure.Additionally, during the procedure, the patient experienced a bowel perforation.It is unknown if the thunderbeat device caused or contributed to the bowel perforation.

• 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: 9127998
• MDR Text Key: 160331874
• Report Number: 8010047-2019-03401
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other