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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP NEEDLE ELECTRODE; ES ACCESSORY
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COVIDIEN LP NEEDLE ELECTRODE; ES ACCESSORY Back to Search Results
Catalog Number E1552
Device Problem Fire (1245)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2014
Event Type  malfunction  
Event Description
The customer reported that while coagulating, a flame was noticed.Another device was used to complete the procedure.There were no injuries to the pt.The site reported that betadine alcohol had been used.
 
Manufacturer Narrative
(b)(4).The return of the incident sample has been requested.To date, it has not been received for evaluation.Additional questions in regard to the incident have been asked.If the sample is received, or if additional info pertinent to the incident is obtained, a follow-up report will be submitted.
 
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Brand Name
NEEDLE ELECTRODE
Type of Device
ES ACCESSORY
Manufacturer (Section D)
COVIDIEN LP
5920 longbow dr.
boulder CO 80301
Manufacturer Contact
sharon murphy, sr dir pmv
5920 longbow dr.
boulder, CO 80301
2034925267
MDR Report Key3945244
MDR Text Key4603553
Report Number1717344-2014-00394
Device Sequence Number1
Product Code JOS
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Catalogue NumberE1552
Device Lot Number33100155X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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