FDA Adverse Event Other Summary report: N

LUMENIS 1

MDR report key: 821927 · Received February 20, 2007

Report

Report Number: 2914019-2006-00124
Event Type: Other
Date Received: February 20, 2007
Date of Event: December 2, 2006
Report Date: February 20, 2007
Manufacturer: LUMENIS, LTD.
Product Code: GEX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN ASSISTANT

Narratives

Additional Manufacturer Narrative · 1

PER THE LUMENIS CUSTOMER ENGINEER CE, THE REPORTED PROBLEM WITH THE LUMENIS ONE DEVICE COULD NOT BE DUPLICATED (THE UNIT TESTED POWER OUTPUT PERFECTLY). THE CUSTOMER'S IPL TREATMENT HEAD HAD 26,000 SHOTS AND HAD BEEN IN SVC FOR 1 ? YRS. LUMENIS RECOMMENDS REPLACEMENT OF LUMENIS ONE IPL TREATMENT HEADS AFTER 30,000 SHOTS OR ONE YR. THE CE RECOMMENDED TO THE CUSTOMER THAT THE IPL TREATMENT HEAD BE REPLACED. THE MOST LIKELY ROOT CAUSE OF THE INCIDENT APPEARS TO BE POSSIBLE UNSTABLE OUTPUT FROM THE OLDER TREATMENT HEAD. AS OF 2/2007, THE CUSTOMER HAD NOT PURCHASED ANY NEW LUMENIS ONE IPL TREATMENT HEADS FROM LUMENIS.

Description of Event or Problem · 1

CUSTOMER CALLED LUMENIS SVC ON 12/22/06 TO REPORT THAT ALTHOUGH THEY HAD AN OPEN SVC CALL WITH LUMENIS AS OF THE SAME DAY, ACTUALLY THEIR PTS HAD BEEN GETTING ODD REACTIONS AFTER TREATMENTS EVER SINCE TWENTY DAYS EARLIER, AND CUSTOMER FELT THAT TOO MUCH POWER WAS COMING FROM THE UNIT. ON INITIAL ANALYSIS, THIS COMPLAINT DID NOT MEET LUMENIS' MDR REPORTING CRITERIA. THE FOLLOWING YEAR, THE CUSTOMER REPORTED THAT THE PTS HAD BEEN GIVEN PRESCRIPTION STRENGTH HYDROCORTISONE, AND THIS INCIDENT WAS DETERMINED BY LUMENIS TO BE MDR REPORTABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LUMENIS 1	COMBINATION INTENSE PULSE LIGHT AND SOLID STATE LASER(S)	GEX	LUMENIS, LTD.	LUMENIS ONE	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*		Required Intervention	NONE REPORTED