VAPORMAX(TM) LASER FIBER

MDR report key: 1073006 · Received July 11, 2008

Report

Report Number: 1419951-2008-00006
Event Type: Malfunction
Date Received: July 11, 2008
Date of Event: May 20, 2008
Report Date: July 11, 2008
Manufacturer: TRIMEDYNE, INC.
Product Code: GEX
PMA / PMN Number: K053457
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

FIBEROPTIC BREAK/SEPARATION. NO CONSEQUENCES OR IMPACT TO PATIENT

Description of Event or Problem · 1

IT WAS REPORTED THAT, "THE PROCEDURE DID NOT GO WELL DUE TO THE FACT THAT THE FIBER BROKE AT THE END OF THE HAND PIECE. THE DOCTOR HAD BEEN LASING FOR ABOUT 10,000 JOULES WHEN THE FIBER SNAPPED. THE POP STARTLED THE PHYSICIAN, WHO DID GET A BURN MARK ON HIS RIGHT HAND GLOVE, BUT NO BURN MARKS TO HIS SKIN. ALL INDICATIONS ARE THAT THE DOCTOR HAD THE FIBER UNDER HIS PALM WHILE HOLDING THE HAND PIECE AND MAY HAVE PUT TOO MUCH PRESSURE ON THE STRESS JOINT OF THE FIBER. THIS IS WHAT WE BELIEVE CAUSED IT TO BREAK. THE PHYSICIAN FINISHED THE CASE WITH A TRADITIONAL TURP. "THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VAPORMAX(TM) LASER FIBER	LASER FIBER	GEX	TRIMEDYNE, INC.	20440	712006

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR