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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC GENCUT; BRONCHOSCOPE (FLEXIBLE OR RIGID)
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COVIDIEN LP - SUPERDIMENSION INC GENCUT; BRONCHOSCOPE (FLEXIBLE OR RIGID) Back to Search Results
Model Number SDCT01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Blood Loss (2597); No Code Available (3191)
Date of Event 04/02/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Bleeding is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during the procedure, patient bleeding occurred.The case was completed however, patient hospitalization was extended.
 
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Brand Name
GENCUT
Common Device Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Manufacturer (Section D)
COVIDIEN LP - SUPERDIMENSION INC
161 cheshire lane, suite 100
plymouth MN 55441
MDR Report Key8551401
Report Number3004962788-2019-00031
Device Sequence Number16233457
Product Code EOQ
UDI-Device Identifier10884521539716
UDI-Public10884521539716
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K142839
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/25/2019
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? No
Operator of Device Health Professional
Device Model NumberSDCT01
Device Catalogue NumberSDCT01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/02/2019
Initial Report FDA Received Date04/25/2019
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 Hospitalization;
Patient Age73 YR
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