FDA Adverse Event Malfunction Summary report: N

THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP

MDR report key: 3973305 · Received June 6, 2014

Report

Report Number: 8010047-2014-00301
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: May 20, 2014
Report Date: May 20, 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 FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 16.5 MM FROM THE DISTAL END. THERE WAS A SCRATCH AT THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE SURGEON ACTIVATED THE DEVICE WHILE THE PROBE HAD CONTACT WITH SOMETHING HARD, AND THE PROBE CRACKED. AFTER THAT, THE PROBE BROKEN WHEN THE SURGEON RETRIEVED THE DEVICE FROM PATIENT BODY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

DURING AN UNCERTAIN PROCEDURE, PROBE DAMAGE ERROR OCCURRED. HOWEVER, THE SURGEON CONTINUED TO USE THE SUBJECT DEVICE. THE ERROR CONTINUED TO OCCUR. AFTER THAT, THE PROBE TIP OF THE SUBJECT DEVICE FELL OFF OUTSIDE THE PATIENT. THE SURGEON REPLACED THE DEVICE WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
331459	THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP	THUNDERBEAT HANDPIECE	GEI	OLYMPUS MEDICAL SYSTEMS CORPORATION	TB-0535FC	K3Z27

Patients

Seq	Age	Sex	Outcome	Treatment
1