MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM,35 CM,FRONT-ACTUATED GRIP TYPE S; INSTRUMENT, ULTRASONIC SURGICAL

Model Number TB-0535FCS

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2022

Event Type  malfunction  

Event Description

During a laparoscopic hysterectomy the disposable handpiece (thunderbeat ref# (b)(4)) broke.A plastic piece on the working end became loose.The piece remained attached to the device.The handpiece was immediately removed and replaced with a new handpiece.

• Brand Name: THUNDERBEAT 5 MM,35 CM,FRONT-ACTUATED GRIP TYPE S
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 15665620
• MDR Text Key: 302343710
• Report Number: 15665620
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Catalogue Number: TB0535FCS
• Device Lot Number: KR239760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female