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Adverse Event Report

XIMED MEDICAL/PROSURG. SINGLE BAR VAPORIZATION ELECTRODE   back to search results
Model Number SB-24CC
Event Date 11/08/1996
Event Type  Malfunction   Patient Outcome  Other;
Event Description

The electrode insulation burnt and the product stopped functioning during the procedure. The customer used another unit and completed the procedure. No harm was done to the patient, doctor or any of the hospital personnel. The procedure was completed satisfactorily using another electrode and no intervention was required.

 
Manufacturer Narrative

Device returned was not electronically functional so failure could not be duplicated.

 
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Brand NameSINGLE BAR
Type of DeviceVAPORIZATION ELECTRODE
Baseline Brand NameSINGLEBAR
Baseline Generic NameELECTRODE
Baseline Model NumberSB-24CC
Baseline Device FamilySINGLE USE ELECTROSURGICAL PROBES
Baseline Device 510(K) NumberK946377
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed03/25/1995
Manufacturer (Section F)
XIMED MEDICAL/PROSURG.
2195 trade zone blvd.
san jose CA 95131
Manufacturer (Section D)
XIMED MEDICAL/PROSURG.
2195 trade zone blvd.
san jose CA 95131
Manufacturer (Section G)
XIMED/PROSURG/INJECTX
2195/2193 trade zone blvd.
san jose CA 95131
Manufacturer Contact
kim khoe
2193 trade zone blvd.
san jose , CA 95131
(408) 945 -4044
Device Event Key86878
MDR Report Key87735
Event Key82564
Report Number2939814-1997-00003
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Remedial Action Replace
Type of Report Initial
Report Date 04/10/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSB-24CC
Device LOT Number069537
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Invalid Data
Date Manufacturer Received11/12/1996
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1995
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 30, 2009

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