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Adverse Event Report

BARD ENDOSCOPIC TECHNOLOGIES, CR BARD RAPID FIRE LIGATOR   back to search results
Model Number 61 000608
Device Problem Deploy, failure to
Event Date 02/01/2002
Event Type  Malfunction  
Event Description

Per contact, during the procedure the md used two kits for one procedure, but the bands did not deploy. A sclerotherapy needle was used to finish procedure.

 
Manufacturer Narrative

Based on previous evaluations of this product for band deployment issues that prolong the procedure, the co is conducting a voluntary recall. Staff person from the boston office has been notified and notices were mailed on 01/31/02. The co has not yet been notified of the recall number.

 
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Brand NameRAPID FIRE
Type of DeviceLIGATOR
Baseline Brand NameRAPIDFIRE
Baseline Generic NameMULTIPLE BAND LIGATOR
Baseline Catalogue Number61 000608
Baseline Model Number61 000608
Baseline Device FamilyLIGATOR
Baseline Device 510(K) NumberK971137
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed11/18/1997
Manufacturer (Section F)
BARD ENDOSCOPIC TECHNOLOGIES, CR BARD
129 concord road bldg.#3
billerica MA 01821
Manufacturer (Section D)
BARD ENDOSCOPIC TECHNOLOGIES, CR BARD
129 concord road bldg.#3
billerica MA 01821
Manufacturer Contact
nancy cutino
129 concord rd bldg #3
billerica , MA 01821
(978) 663 -8989
Device Event Key365231
MDR Report Key376145
Event Key354942
Report Number1223688-2002-00009
Device Sequence Number1
Product CodeMND
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 02/06/2002,02/01/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/01/2003
Device MODEL Number61 000608
Device Catalogue Number61 000608
Device LOT Number88JL0975
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/01/2002
Device Age4 mo
Event Location Hospital
Date Manufacturer Received02/01/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 06, 2009

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