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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN LP BARRX BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 90-9100
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event 12/18/2017
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 literature source of study performed, pain and dysphagia was experienced by 36 patients at 3 weeks post procedure.The pain and dysphagia that persisted after adjusting for significant variables including indication for ablation, type of procedural sedation, and whether medication was prescribed for pain after the procedure were provided in a scale.
 
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Brand Name
BARRX
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
MDR Report Key8401928
Report Number3004904811-2019-00007
Device Sequence Number19340257
Product Code GEI
UDI-Device Identifier10884521189362
UDI-Public10884521189362
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093008
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,literatur
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/07/2019
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 Number90-9100
Device Catalogue Number90-9100
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/11/2019
Initial Report FDA Received Date03/07/2019
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 Other;
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