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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES
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COVIDIEN MFG DC BOULDER VALLEYLAB; UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES Back to Search Results
Model Number E6008B
Medical Device Problem Codes Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/18/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, intra-operatively, the device¿s foot pedal had no coagulation output.As a result, the procedure was interrupted.There was no patient injury.
 
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Brand Name
VALLEYLAB
Common Device Name
UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key7176322
Report Number1717344-2018-00037
Device Sequence Number2001334
Product Code BWA
UDI-Device Identifier10884524001647
UDI-Public10884524001647
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K874794
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberE6008B
Device Catalogue NumberE6008B
Device Lot Number187953/3X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/19/2017
Initial Report FDA Received Date01/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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