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Adverse Event Report

XIMED MEDICAL/PROSURG. SINGLE BAR VAPORIZING ELECTRODE   back to search results
Model Number SB-24C
Event Date 07/31/1995
Event Type  Other   Patient Outcome  Other;
Event Description

The electrode 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 and no intervention was required.

 
Manufacturer Narrative

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

 
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Brand NameSINGLE BAR
Type of DeviceVAPORIZING ELECTRODE
Baseline Brand NameSINGLEBAR
Baseline Generic NameELECTRODE
Baseline Model NumberSB-24C
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 Key86889
MDR Report Key87746
Event Key82575
Report Number2939814-1997-00001
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Remedial Action Replace
Type of Report Initial
Report Date 04/11/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/1997
Is This An Adverse Event Report? No
Device Operator Health Professional
Device MODEL NumberSB-24C
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Invalid Data
Was Device Evaluated By Manufacturer? Yes
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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