FDA Adverse Event Malfunction Summary report: N

THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

MDR report key: 4073635 · Received August 21, 2014

Report

Report Number: 8010047-2014-00457
Event Type: Malfunction
Date Received: August 21, 2014
Date of Event: July 25, 2014
Report Date: July 28, 2014
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD WAS PARTIALLY PEELED FROM THE JAW. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND THE JAW. THE MFG RECORD WAS REVIEWED WITH NO IRREGULARITIES. BASED ON SIMILAR CASES WITH THE SAME MODEL, IT IS KNOWN THAT BY CONTINUOUSLY ACTIVATING OUTPUT WITHOUT GRASPING ANYTHING IN THE GRASPING SECTION (INCLUDING AFTER THE TISSUE SEPARATED), THE PTFE PAD SEVERELY WORN, AND THE DISTAL END OF THE PAD IS SEPARATED FROM THE GRASPING SECTION. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE USER CONTINUED ACTIVATING OUTPUT FOR AN EXTENDED TIME AFTER THE TISSUE ALREADY CUT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

THE SUBJECT DEVICE WAS USED DURING A LAPAROSCOPIC REPAIR OF INGUINAL HERNIA. AFTER ABOUT 3 TIMES OUTPUT WITH SEAL AND CUT MODE, THE PTFE PAD OF THE DEVICE WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT DEVICE. THERE WAS NO PT INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
505127	THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP	THUNDERBEAT HANDPIECE	GEI	OLYMPUS MEDICAL SYSTEMS CORPORATION	TB-0535FC	K4430

Patients

Seq	Age	Sex	Outcome	Treatment
1