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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 Temperature Problem (3022)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/20/2017
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, prior to use, the product was connected to the generator, temperature was not stable.No patient involvement.Another product was used to complete the case.
 
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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 Key7180603
Report Number1717344-2018-00044
Device Sequence Number1274478
Product Code GEI
UDI-Device Identifier10884524001210
UDI-Public10884524001210
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K973297
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/10/2018
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 Expiration Date10/04/2020
Device Model NumberACT2020
Device Catalogue NumberACT2020
Device Lot Number72930099X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2017
Initial Report FDA Received Date01/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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