MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION THUNDERBEAT; UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number TB-0535FC

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  malfunction  

Event Description

The probe tip broke off while in use and was recovered.There was no harm to the patient.Vendor representative present at time of event.The event was discussed with the surgeon.

• Brand Name: THUNDERBEAT
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6841567
• MDR Text Key: 84643291
• Report Number: 6841567
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: TB-0535FC
• Device Lot Number: MK662591
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1