MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS, CORP. THUNDERBEAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number TB-0535FCS (5MM, 35 CM)

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2021

Event Type  malfunction  

Event Description

Tip of thunderbeat product broke off inside of patient during a laparoscopic hysterectomy procedure.Fda safety report id# (b)(4).

• Brand Name: THUNDERBEAT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS, CORP.; 2951 ishikawa-cho, hachio; tokyo 192-8 507; JA 192-8507
• MDR Report Key: 13207218
• MDR Text Key: 283618817
• Report Number: MW5106549
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS (5MM, 35 CM)
• Device Lot Number: KR114552
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White