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Adverse Event Report

CONMED ELECTROSURGERY CONMED ABC LAPAROSCOPIC HANDPIECE   back to search results
Model Number ABC PROBE
Event Date 11/01/2003
Event Type  Malfunction  
Event Description

The insulation of the probe was rolled back exposing the metal electrode which fell out. There was no injury to the pt.

 
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Brand NameCONMED
Type of DeviceABC LAPAROSCOPIC HANDPIECE
Baseline Brand NameCONMED
Baseline Generic NameABC LAPAROSCOPIC HANDPIECE
Baseline Catalogue Number160656
Baseline Model NumberABC PROBE
Baseline Device FamilyABC PROBE
Baseline Device 510(K) NumberK925903
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed12/30/1992
Manufacturer (Section F)
CONMED ELECTROSURGERY
14603 east fremont ave
centennial CO 80112
Manufacturer (Section D)
CONMED ELECTROSURGERY
14603 east fremont ave
centennial CO 80112
Manufacturer Contact
rebecca bernie, specialist
14603 east fremont ave
centennial , CO 80112
(303) 699 -7600 ext 5225
Device Event Key495196
MDR Report Key506325
Event Key480228
Report Number1720159-2003-00132
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/25/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/2008
Device MODEL NumberABC PROBE
Device Catalogue Number160656
Device LOT Number030815-1
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/25/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2003
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 February 28, 2009

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