FDA.reportPublic FDA data

MAUDE MDR 8484171

MDR report key
8484171
Report number
1528319-2019-00015
Event key
0
Event type
3
Date of event
2019-02-09
Date received
2019-04-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. COLETTA COHARA
Address
5976 HEISLEY RD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RAPTOR GRASPING DEVICEGRASPING DEVICEUNITED STATES ENDOSCOPY GROUP, INC.OCZ00711177007111771820710Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-040

Event Narratives#

N

Patient 1

THE USER FACILITY WAS CONTACTED BY US ENDOSCOPY BUT HAS DECLINED TO PROVIDE ANY INFORMATION REGARDING THE PROCEDURE ASIDE FROM THAT THERE WAS NO HARM TO THE PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE DEVICES WERE MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. THE DEVICE SUBJECT OF THE EVENT WAS RETURNED TO US ENDOSCOPY FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED THAT, CONTRARY TO THE INITIAL REPORT, NO PORTION OF THE DEVICE APPEARS TO HAVE DETACHED DURING USE. THE DRIVE WIRES OF THE DEVICE WERE BENT IN A MANNER WHICH INDICATES THE DEVICE DAMAGE WAS DUE TO THE APPLICATION OF EXCESSIVE FORCE BY THE USER. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING STATEMENTS: "DO NOT USE EXCESSIVE FORCE ON THE HANDLE AND DO NOT COIL THE CATHETER OUTSIDE OF THE ENDOSCOPE. EXCESSIVE FORCE OR COILING MAY DAMAGE THE DEVICE... APPLY CONTINUOUS GENTLE TRACTION WHILE SQUEEZING THE SLIDER TOWARD THE THUMB RING. DO NOT USE EXCESSIVE FORCE OR COIL THE SHEATH OUTSIDE OF THE ENDOSCOPE. THIS MAY DAMAGE THE DEVICE AND RENDER IT INOPERABLE. KEEPING THE OBJECT SECURED IN THE GRASPING JAWS, WITHDRAW THE OBJECT TOGETHER WITH THE ENDOSCOPE FROM THE PATIENT. DO NOT RETRACT THE DEVICE AND THE OBJECT INTO THE ENDOSCOPE; THIS COULD CAUSE DAMAGE TO THE ENDOSCOPE AND THE DEVICE." US ENDOSCOPY HAS OFFERED IN-SERVICE TRAINING ON THE USE OF THE DEVICE. HOWEVER, THE USER FACILITY HAS DECLINED. THERE HAVE BEEN NO FURTHER ISSUES REPORTED.

D

Patient 1

REFERENCE USER FACILITY MEDWATCH REPORT #5084083. THE USER FACILITY REPORTED THAT A RAPTOR GRASPING DEVICE BROKE DURING A PROCEDURE, NECESSITATING RETRIEVAL OF A PORTION OR PORTIONS OF THE DEVICE. THERE WERE NO INJURIES ASSOCIATED WITH THE REPORTED EVENT.