MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number TB-0545FC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/12/2017

Event Type  malfunction  

Event Description

Thunderbeat (olympus) device sensor malfunction, "check for metal in jaws of device".

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; laura storms; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 6961389
• MDR Text Key: 89747502
• Report Number: 6961389
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170337543
• UDI-Public: (01)04953170337543
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 06/26/2020
• Device Model Number: TB-0545FC
• Device Catalogue Number: TB-0545FC
• Device Lot Number: MK658116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Age: 68 YR