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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN LP - SUPERDIMENSION INC EMPRINT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number CA190RC1
Medical Device Problem Codes Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/12/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during ablation, the cable could not be connected with the antenna.Procedure was aborted but the patient was under general anesthesia.
 
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Brand Name
EMPRINT
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN LP - SUPERDIMENSION INC
161 cheshire lane, suite 100
plymouth MN 55441
MDR Report Key9902167
Report Number3004962788-2020-00019
Device Sequence Number644075
Product Code GEI
UDI-Device Identifier10884521190764
UDI-Public10884521190764
Combination Product (Y/N)N
Initial Reporter CountryIS
PMA/510(K) Number
K133821
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) 03/31/2020
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 NumberCA190RC1
Device Catalogue NumberCA190RC1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2020
Initial Report FDA Received Date03/31/2020
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 Other;
Patient Age75 YR
Patient Weight90
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