DOUBLE HEADER ENDOSCOPE BRUSH 00711609

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for DOUBLE HEADER ENDOSCOPE BRUSH 00711609 manufactured by United States Endoscopy Group, Inc. / Steris Corp..

Event Text Entries

[133716081] At the end of the procedure, the suction button became fixed in the depressed position. After some manipulation, we were able to free up the button and complete the case. The suction button was removed with some difficulty. During post procedure cleaning of the scope, a brush end was found lodged in the suction port.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083189
MDR Report Key8256873
Date Received2019-01-16
Date of Report2019-01-15
Date of Event2018-12-18
Date Added to Maude2019-01-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDOUBLE HEADER ENDOSCOPE BRUSH
Generic NameACCESSORIES, CLEANING BRUSHES FOR ENDOSCOPE
Product CodeMNL
Date Received2019-01-16
Catalog Number00711609
Lot Number1808455
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNITED STATES ENDOSCOPY GROUP, INC. / STERIS CORP.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-16

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