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

BALLARD MEDICAL PRODUCTS NEEDLE KNIFE PAPILLOTOME   back to search results
Catalog Number 62228
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

During diathermy of the papilla of vater, approximately 1. 5cm of the cutting wire broke off in the papilla. The wire was removed with a biopsy/grasper forcep. No other info is available.

 
Manufacturer Narrative

The device was not returned for eval.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameNEEDLE KNIFE PAPILLOTOME
Type of DevicePAPILLOTOME
Baseline Brand NameBALLARD PAPILLOTOME
Baseline Generic NamePAPILLOTOME
Baseline Catalogue Number62228
Baseline Device FamilyPAPILLOTOMES
Baseline Device 510(K) NumberK894861
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed12/21/1989
Manufacturer (Section F)
BALLARD MEDICAL PRODUCTS
12050 lone peak parkway
draper UT 84020
Manufacturer (Section D)
BALLARD MEDICAL PRODUCTS
12050 lone peak parkway
draper UT 84020
Manufacturer Contact
cindy ellis
12050 lone peak parkway
draper , UT 84020
(801) 572 -6800
Device Event Key355309
MDR Report Key366186
Event Key345268
Report Number3031042-2001-00057
Device Sequence Number1
Product CodeKOG
Report Source Manufacturer
Source Type Distributor
Reporter Occupation UNKNOWN
Remedial Action Other
Type of Report Initial
Report Date 11/14/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date02/01/2005
Device Catalogue Number62228
Device LOT Number125792
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/14/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 06, 2009

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