MAUDE Adverse Event Report: OLYMPUS SURGICAL TECHNOLOGIES AMERICA THUNDERBEAT ELECTROSURGICAL UNIT; ELECTROSURGICAL , CUTTING AND COAGULATION AND ACCESSORIES

Model Number TB-0535FC

Device Problems Break (1069); Material Discolored (1170); Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a case was being conducted at (b)(6) in (b)(6) using an olympus thunderbeat.As the electrosurgical unit was being used the active electrode broke causing a component of the device to dislodge and become trapped in the pt.Once the device removed from the pt, it was noticed that the active electrode had become discolored (blackened) where the component had broken off.There was no harm to the pt and the case was completed.I reported this to olympus directly and filed a report with our risk manager here.Fda safety report id# (b)(4).

• Brand Name: THUNDERBEAT ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL , CUTTING AND COAGULATION AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS SURGICAL TECHNOLOGIES AMERICA
• MDR Report Key: 8605089
• MDR Text Key: 145081136
• Report Number: MW5086584
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170337574
• UDI-Public: (01)04953170337574
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: TB-0535FC
• Device Catalogue Number: TB-0535FC
• Device Lot Number: KR824648
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 58