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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number E2100
Medical Device Problem Code Self-Activation or Keying (1557)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/30/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, when the pencil was used in conjunction with the equipment, it had intermittent and spontaneous activation of cut function when the coagulation function was activated.There was no patient involvement.
 
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Brand Name
VALLEYLAB
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key11259903
Report Number1717344-2021-00154
Device Sequence Number14295850
Product Code GEI
UDI-Device Identifier20884524001590
UDI-Public20884524001590
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K942183
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/01/2021
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 Expiration Date07/01/2019
Device Model NumberE2100
Device Catalogue NumberE2100
Device Lot Number41730030X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/11/2021
Initial Report FDA Received Date02/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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