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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 E2401
Medical Device Problem Code Detachment Of Device Component (1104)
Health Effect - Clinical Code No Information (3190)
Date of Event 03/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during a video-assisted thoracoscopy, the patient had retained a radiopaque stripe of the surgical pencil scratch pad.It was decided that the foreign body would be removed during another scheduled surgery.
 
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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 Key7500025
Report Number1717344-2018-00659
Device Sequence Number13480891
Product Code GEI
UDI-Device Identifier10884524001821
UDI-Public10884524001821
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K882646
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Report Source health professional,user faci
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberE2401
Device Catalogue NumberE2401
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/09/2018
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 Required Intervention;
Patient Age16 YR
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