FDA.reportPublic FDA data

MAUDE MDR 248885

MDR report key
248885
Report number
MW1017495
Event key
0
Event type
3
Date of event
1999-10-27
Date received
1999-11-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HGM PCC-EDO 2.5WLASERHGM, INC.GFXPC-EDO 2.5W NON-SMARTOLS01B2B01D*NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-11-080

Event Narratives#

D

Patient 1

EQUIPMENT HAD BEEN AWAITING INSTALLATION BY HGM, SINCE EARLY SEPTEMBER 1999. THE CO WAS UNABLE TO COMPLETE THE INSTALL, "DUE TO PERSONNEL PROBLEMS". AFTER REPEATED REQUESTS WERE MADE A REP WAS DISPATCHED AND HE ATTEMPTED TO OPERATE THE LASER. THE UNIT'S CIRCUIT BREAKER TRIPPED AND WOULD NOT RESET. WHEN THE CASE WAS OPENED, NO OBVIOUS FAULT WAS SEEN SO POWER WAS RETURNED AND AN ARC WAS SEEN TO RISE FROM THE POWER SUPPLY, ACCOMPANIED BY A LOUD POP. A WIRE WAS FOUND TO HAVE INSULATION DAMAGE DUE TO CONTACT WITH A METAL CASE. THIS WAS REPAIRED, BUT THE SYSTEM STILL WOULD NOT WORK. THE HGM REP SAID THE PROBLEM WAS DUE TO SOME "LEAKY" CAPACITORS THAT "SHOULD NEVER HAVE BEEN IN THE PRODUCTION AREA, AS THEY WERE KNOWN TO BE BAD..." REPORTER IS STILL WAITING.