SMART CAPNODION 02 LONG 010128

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-01 for SMART CAPNODION 02 LONG 010128 manufactured by Oridion Medical.

Event Text Entries

[1448700] Smart capno found to break apart. On multiple occasion (at least three), physicians observed the thin ring with plastic clear flap get dislodged from the biteblock while inserting the endoscope for an upper endoscopy. No harm was done to any patient and all biteblocks were removed from the procedure rooms. The company was notified.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5014627
MDR Report Key1595215
Date Received2010-02-01
Date of Report2010-02-01
Date of Event2009-11-16
Date Added to Maude2010-02-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSMART CAPNODION 02 LONG
Generic NameBITEBLOCK
Product CodeJXL
Date Received2010-02-01
Returned To Mfg2005-11-24
Model Number010128
Lot NumberM718769
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerORIDION MEDICAL
Manufacturer Address7 HAMARPE ST. JERUSALEM 97774 IS 97774

Device Sequence Number: 2

Brand NameSMART CAPNIODION 02 LONG
Generic NameBITEBLOCK
Product CodeJXL
Date Received2010-02-01
Returned To Mfg2005-11-24
Lot NumberM692009
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerORIDION MEDICAL
Manufacturer Address7 HAMARPE ST. JERUSALEM 97774 IS 97774

Patients

Patient NumberTreatmentOutcomeDate
10 2010-02-01
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