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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN MFG DC BOULDER COOL-TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number ACT2020
Medical Device Problem Code Peeled/Delaminated (1454)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/22/2020
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, during radiofrequency ablation, the ablation range was defective and the nano coating was damaged.A similar device was used to complete the procedure.There was no patient injury.
 
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Brand Name
COOL-TIP
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key10137705
Report Number1717344-2020-00607
Device Sequence Number1800116
Product Code GEI
UDI-Device Identifier10884524001210
UDI-Public10884524001210
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K973297
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/10/2020
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 Date06/18/2021
Device Model NumberACT2020
Device Catalogue NumberACT2020
Device Lot Number81700158X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/26/2020
Initial Report FDA Received Date06/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age45 YR
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