VERSAPULSE POWERSUITE 100W

Report

Report Number: 3004135191-2017-00130
Event Type: Injury
Date Received: September 27, 2017
Date of Event: September 23, 2015
Report Date: September 27, 2017
Manufacturer: LUMENIS LTD.
Product Code: GEX
PMA / PMN Number: K011703
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO THE REPORT, UNNAMED 200 LASER FIBERS WERE USED DURING THE REPORTED EVENT; HOWEVER THE BATCH NUMBER #00002289 HAD BEEN PROVIDED. A SEARCH IN THE LUMENIS DATABASE DOES NOT IDENTIFY #00002289 AS A VALID LUMENIS BATCH NUMBER. IT HAD BEEN DETERMINED THAT NON-LUMENIS FIBERS HAD BEEN USED DURING THE REPORTED EVENT. AS PART OF A REMEDIAL ACTIVITY, LUMENIS CONDUCTED A RETROSPECTIVE REVIEW OF ALL ITS SAFETY COMPLAINT FILES FROM JANUARY 2015 - JULY 2017. AN INVESTIGATION OF THE REPORTED EVENT FOUND THAT THE REPORTED MALFUNCTION OF A NON-LUMENIS FIBER CONNECTOR OVERHEATING WAS SIMILAR TO A DEVICE MALFUNCTION THAT RESULTED IN A POTENTIALLY HARMFUL SITUATION (MDR# 3004135191-2017-00024). LUMENIS CONTACTED THE REPORTER OF THE REPORTED EVENT TO OBTAIN MORE INFORMATION REGARDING THE SEVERITY OF THE BURN, HOW THE BURN WAS TREATED, AND TO FIND OUT IF THE BURN HAD COMPLETELY HEALED; HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED. THE FACILITY'S BIOMED TECH AND LASER SAFETY OFFICER CONFIRMED ""THERE WAS A CASE TO FOLLOW THAT CASE (WHERE THE NURSE BURNED HER FINGERS) AND BECAUSE THE NEW FIBER WORKED TO FINISH THE CASE, THE NEXT CASE PROCEEDED WITHOUT INCIDENT. THE FOLLOWING DAY THE BIOMED TECH TESTED THE LASER WITH A TEST FIBER AND DEEMED IT TO BE IN PROPER WORKING ORDER." A SIMILAR COMPLAINT SEARCH WAS PERFORMED IN LUMENIS'S COMPLAINT MANAGEMENT SYSTEM, WHICH REVEALED NO EVENTS INVOLVING LUMENIS 200 FIBERS AND USERS BEING BURNED ON OVERHEATED LASER FIBER CONNECTORS HAD EVER BEEN REPORTED. BASED ON THE INFORMATION ABOVE, THE MOST PROBABLE ROOT CAUSE OF THE EVENT WAS A MALFUNCTION OF A NON-LUMENIS 200 FIBER. LUMENIS IS REPORTING THIS EVENT SINCE A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE ADVERSE EVENT. ALTHOUGH NO REPORT OF SERIOUS INJURY WAS RECEIVED AND NO REPORT OF MEDICAL INTERVENTION REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OR SERIOUS INJURY WAS RECEIVED, LUMENIS CANNOT RULE OUT THAT A SERIOUS INJURY HAD OCCURED. ALTHOUGH THERE IS NO EVIDENCE THAT A LUMENIS PRODUCT HAD MALFUNCTIONED IN THIS EVENT, LUMENIS IS STILL REPORTING THIS EVENT AS A PRODUCT PROBLEM/MALFUNCTION SINCE A LUMENIS LASER SYSTEM WAS A CONTRIBUTORY PART OF THE ADVERSE EVENT. THE INVESTIGATION FOR THIS AND SIMILAR EVENTS IS BEING HANDLED UNDER (B)(4).

Description of Event or Problem · 1

A USER FACILITY REPORTED THAT DURING A CASE OF LEFT URETEROSCOPY WITH LASER LITHOTRIPSY AND STENT PLACEMENT IN WHICH A LUMENIS VERSAPULSE POWERSUITE LASER WAS UTILIZED, THE OPERATOR WAS COMPLAINING THAT THE LASER WAS NOT WORKING WELL. THE LASER NURSE WENT TO CHANGE THE LASER FIBER, AND AS THE NURSE WENT TO REMOVE THE LASER FIBER FROM THE SYSTEM, SHE GRABBED THE CONNECTOR AND BURNED HER INDEX FINGER AND THUMB. SHE QUICKLY GOT SOME COLD WATER ONTO THE AREA BUT IT STILL RESULTED IN A SIZABLE BURN/BLISTER. NO INFORMATION REGARDING MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED. THE PROCEDURE WAS CONTINUED WITH A SECOND FIBER WITHOUT INCIDENT AND NO ADDITIONAL INJURIES HAD BEEN REPORTED. IT HAD ALSO BEEN REPORTED THAT THE FIBERS USED DURING THE PROCEDURE WERE NOT SAVED AND NO LONGER AVAILABLE FOR EXAMINATION. NO REPORT OF WHICH FIBER TYPE OR MODEL WAS USED, OTHER THAN THAT THEY WERE 200 FIBERS WITH THE BATCH NUMBER #00002289.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
678037	VERSAPULSE POWERSUITE 100W	HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS	GEX	LUMENIS LTD.	VERSAPULSE POWERSUITE 100 W

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other