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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
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COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) Back to Search Results
Model Number E1560
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Radiation Exposure, Unintended (3164)
Date of Event 05/21/2019
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 elective large loop excision of the transformation zone (lletz) of cervix, a section of the loop was missing.The remains of the loop was not found even after thorough examination of the vagina and x-ray of the pelvix was performed.
 
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Brand Name
VALLEYLAB
Common Device Name
ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key8709418
Report Number1717344-2019-00781
Device Sequence Number16666954
Product Code HGI
UDI-Device Identifier10884524000237
UDI-Public10884524000237
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K931338
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/18/2019
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 NumberE1560
Device Catalogue NumberE1560
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/24/2019
Initial Report FDA Received Date06/18/2019
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;
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