ENDOCATCH 10 MM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-17 for ENDOCATCH 10 MM * manufactured by Covidien, Llc.

Event Text Entries

[5846421] We have had several reported instances where, after the endocatch bag with the specimen in it has been removed from the retractable ring, the remaining piece of plastic bag on the ring has fallen off inside the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4855737
MDR Report Key4855737
Date Received2015-06-17
Date of Report2015-06-17
Date of Event2015-05-28
Report Date2015-06-17
Date Reported to FDA2015-06-17
Date Reported to Mfgr2015-06-19
Date Added to Maude2015-06-19
Event Key0
Report Source CodeUser Facility 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 FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameENDOCATCH
Generic NameLARYNGOSCOPE, ENDOSCOPE
Product CodeCAL
Date Received2015-06-17
Model Number10 MM
Catalog Number*
Lot NumberUNK
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Age*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN, LLC
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-17

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