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Adverse Event Report

BARD ENDOSCOPIC TECHNOLOGIES, CR BARD RAPID FIRE LIGATORS   back to search results
Model Number 61 000608
Device Problem Premature deployment
Event Date 12/01/2003
Event Type  Malfunction  
Event Description

Per rep and contact; during the procedure the bands fired prematurely causing the second band to fire at the same time as the first. Rep said dr said suction was a problem. The varices were an unk size. Nurse states bander did not seat correctly at the end of the scope. A second ligator was used and had a similar problem. A third ligator was used to complete the procedure.

 
Manufacturer Narrative

No product was returned for evaluation; however, a device history review was performed and no deviations or nonconformances were found with lot #88lm0348.

 
Search Alerts/Recalls

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Brand NameRAPID FIRE
Type of DeviceLIGATORS
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 rd., bldg. 3
billerica MA 01821
Manufacturer (Section D)
BARD ENDOSCOPIC TECHNOLOGIES, CR BARD
129 concord rd., bldg. 3
billerica MA 01821
Manufacturer (Section G)
C.R. BARD, INC. (BIP/MENTOR)
6091 heisley rd.
mentor OH 44060
Manufacturer Contact
clare donelan
129 concord road bldg #3
billerica , MA 01821
(978) 663 -8989
Device Event Key500285
MDR Report Key511318
Event Key485084
Report Number1223688-2003-00079
Device Sequence Number1
Product CodeMND
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 12/18/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/01/2004
Device MODEL Number61 000608
Device Catalogue Number61 000608
Device LOT Number88LM0348
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/01/2003
Device Age12 mo
Event Location Hospital
Date Manufacturer Received12/18/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2002
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on January 30, 2009

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