FDA.reportPublic FDA data

MAUDE MDR 273654

MDR report key
273654
Report number
1038548-2000-00001
Event key
0
Event type
3
Date of event
1999-11-11
Date received
2000-04-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS LEIGH GAYLE, SPECIALIST
Address
5175 S. ROYAL ATLANTA DR TUCKER GA 30084 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DJ GRASPER 5MMGRASPERGENZYME SURGICAL PRODUCTS CORP.GCJNA90-3004C99K960400NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-04-1401. R

Event Narratives#

D

Patient 1

DURING A LAPAROSCOPIC GALL BLADDER PROCEDURE, THE COMPLAINANT ALLEGED THAT THEY OBSERVED A PIECE OF THE INSTRUMENT LYING ON THE FLOOR OF THE ABDOMEN WHERE THE GRASPER WAS BEING USED TO GRASP. THE INSTRUMENT PIECE WAS REMOVED AND RETURNED TO "GSP" FOR EVAL AND TO ENSURE THAT ALL PARTS WERE PRESENT. THE PHYSICIAN PERFORMED AN X-RAY TO ENSURE NO PARTS REMAINED IN PT.