SUPERTRAX BIOPSY FORCEPS SDBF1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-24 for SUPERTRAX BIOPSY FORCEPS SDBF1000 manufactured by Superdimension Inc..

Event Text Entries

[48108934] The device was not returned for evaluation. The inspection record was reviewed and there were no anomalies observed associated to this issue. Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy. If additional information is received a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[48108935] A patient received an asymptomatic pneumothorax during a superdimension enb procedure biopsy, it was found on a post procedure x-ray. The patient was observed for 2 hours and then discharged. If additional information is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004962788-2016-00172
MDR Report Key5747868
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-06-24
Date of Report2016-06-06
Date of Event2016-06-03
Date Mfgr Received2016-06-06
Device Manufacturer Date2016-04-11
Date Added to Maude2016-06-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHARON MURPHY
Manufacturer Street161 CHESHIRE LANE SUITE 100
Manufacturer CityMINNEAPOLIS MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone2034925267
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPERTRAX BIOPSY FORCEPS
Generic NameBIOPSY FORCEPS
Product CodeBWH
Date Received2016-06-24
Model NumberSDBF1000
Lot NumberRLT015351
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSUPERDIMENSION INC.
Manufacturer Address161 CHESHIRE LANE SUITE 100 MINNEAPOLIS MN 55441 US 55441


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-06-24

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