MAUDE MDR 571870

MDR report key
571870
Report number
MW1034591
Event key
0
Event type
3
Date of event
2004-12-08
Date received
2004-12-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Related Records

Manufacturer Contact

Report source
P
Manufacturer link flag
N

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENDOSCRUB2*XOMEDKARENDOSCRUB2**NY
2ENDOSCRUB2*XOMEDKARENDOSCRUB2**NY

Patients

SequenceReceivedTreatmentOutcome
12004-12-080

Event Narratives

D

Patient 1

ENDO SCRUB 2 MADE BY XOMED APPEARS TO BE GROUNDING ON METAL IV POLE AND RUNNING CONTINUOUSLY WITHOUT INPUT FROM THE FOOTPEDAL CONTROL DEVICE. THE DEVICE IS SUPPOSED TO RUN ONLY WHEN THE FOOTPEDAL IS DEPRESSED. THESE 2 MACHINES HAVE BEEN IN SERVICE FOR APPROXIMATELY ONE YEAR AND HAD WORKED WITH NO PROBLEMS WHEN THEY BOTH FAILED THE SAME WAY ABOUT THE SAME TIME. A FAULT IN THE FOOTPEDAL WAS INTIALLY SUSPECTED BUT A REPLACEMENT FOOTPEDAL HAD THE SAME PROBLEM. THESE DEVICES ARE MADE TO BE MOUNTED ON A METAL IV POLE. WHEN THE MACHINE IS TAKEN OFF THE IV POLE IT RUNS PROPERLY, LEADING RPTR TO CONCLUDE THAT THERE IS AN "ELECTRICAL" IN THE MACHINES WHICH ALLOWS GROUNDING TO THE IV POLE. RPTR IS CONCERNED THAT THIS IS A DANGER TO OR PERSONNEL. RPTR DOES NOT THINK IT MUCH OF A DANGER TO PTS AS THERE IS NO REASON FOR THE POLE TO CONTACT THE POLE. RPTR IS NOT AN ELECTRICIAN BUT IS CONCERNED ABOUT THIS. NO ONE HAS BEEN HARMED TO DATE BY THIS. THESE DEVICES ARE IN THE OPERATING ROOM AT THE MEDICAL CENTER. IT IS USED TO IRRIGATE SINUSCOPES TO CLEAN BLOOD AND SECRETIONS OFF.

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