FDA Adverse Event Other Summary report: N

VERSAPULSE SELECT

MDR report key: 744149 · Received June 28, 2005

Report

Report Number: 2914019-2005-00030
Event Type: Other
Date Received: June 28, 2005
Date of Event: December 7, 2004
Report Date: June 28, 2005
Manufacturer: COHERENT MEDICAL GROUP
Product Code: GEX
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

LUMENIS FSE VISITED ON 12/14/2005 TO CHECK THE UNIT. THE EMERGENCY OFF BUTTON HAD ENGAGED DURING THE PROCEDURE. FSE DETERMINED THAT UNIT DID NOT START FROM THE KEYSWITCH ON AND THAT EMERGENCY STOP SWITCH WAS STUCK IN THE DOWN POSTION. FSE FOUND STICKY MATERIAL BEHIND THE BUTTON AND REPAIRED (CLEANED) THE BUTTON. FSE DEMONSTRATED UNIT TO CUSTOMER STAFF FOLLOWING THE SERVICE PROVIDED. ROOT CAUSE OF THIS INCIDENT WAS POOR MAINTENANCE (FAILURE TO MAINTAIN THE UNIT CONTROLS IN A CLEAN CONDITION). NO FURTHER PROBLEMS WITH LASER PER TELECONFERENCE WITH CUSTOMER BIOMED DEPARTMENT ON 02/08/2005.

Description of Event or Problem · 1

CUSTOMER FILED USER FACILITY MDR WITH FOLLOWING DESCRIPTION: "COHERENT LASER PRETESTING COMPLETED. LASER WAS WARMED UP AND FUNCTIONAL. WHEN PHYSICIANS WERE ABOUT TO USE LASER, IT SHUT DOWN BY ITSELF. ATTEMPTS TO RE-START WERE UNSUCCESSFUL. CLINICAL ENGINEERING CHECKED AND WILL REPAIR. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING.)" COHERENT INC RECEIVED A COPY OF THE USER FACILITY MDR REPORT ON 1/14/2005 AND FORWARDED IT TO LUMENIS WHERE IT WAS RECEIVED ON 1/18/2005 AND A SAFETY INVESTIGATION WAS OPENED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VERSAPULSE SELECT	SURGICAL LASERS	GEX	COHERENT MEDICAL GROUP	VERSAPULSE SELECT	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*			"NOT APPLICABLE" PER USER FACILITY MDR REPORT