FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

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 03/05/2002
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Event Description

Per contact, the md used three devices to band varices in the esophagus of one pt. Out of 15 bands, approximately two fired correctly and banded the varices but per the nurse the bands slipped off and the md injected the veins. Procedure was prolonged requiring add'l anesthesia and an over night hospital stay.

 
Manufacturer Narrative

Customer had two lots numbers (88gl0493 and 88gl0847), but is not sure which lots were used. Both of these lots are included in the voluntary recall by bet initiated on 1/2002. Customer claims that they did not receive the recall notice, although certified receipt was made on 2/02.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

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 road bldg #3
billerica , MA 01821
(978) 663 -8989
Device Event Key370831
MDR Report Key381784
Event Key360438
Report Number1223688-2002-00025
Device Sequence Number1
Product CodeMND
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 03/12/2002,03/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number61 000608
Device Catalogue Number61 000608
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/05/2002
Device Ageunknown
Event Location Hospital
Date Manufacturer Received03/07/2002
Was Device Evaluated By Manufacturer? No
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 December 31, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH