ESOPHYX2 HD C02042-01 R2005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for ESOPHYX2 HD C02042-01 R2005 manufactured by Endogastric Solutions, Inc..

Event Text Entries

[75927681] The device was available from the hospital for evaluation; an engineering device evaluation was performed on the returned product. The retractor control cable was found encumbered by the scope retainer band and the helix and centering needle were bent. The tissue mold was fully operational although some drag was noted when opening/closing the tissue mold. The drag was caused by the helical control cable being wedged in the tissue mold as the result of being encumbered by the scope retainer band. A review of the dhr indicates the materials and assembly process were to specifications and passed all final testing criteria. The root cause of the helical control cable caught in the scope retainer band could not be definitively determined. This is the second reported occurrence in 17,245 procedures (0. 012%). There is no reported patient injury; however, if the failure were to recur, it may require intervention to prevent serious injury.
Patient Sequence No: 1, Text Type: N, H10


[75927682] The user reported the tissue mold would not open or close as expected. As a result, the user was unable to manipulate the tissue mold to properly position tissue. The initial device was uneventfully removed and the procedure was successfully completed with a secondary r2005 device. There is no reported patient impact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005473391-2017-00103
MDR Report Key6586499
Date Received2017-05-23
Date of Report2017-05-18
Date of Event2017-04-10
Date Mfgr Received2017-04-24
Device Manufacturer Date2016-10-18
Date Added to Maude2017-05-23
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 ContactMR. JAMES BROOKS
Manufacturer Street18109 NE 76TH STREET SUITE 100
Manufacturer CityREDMOND WA 980525022
Manufacturer CountryUS
Manufacturer Postal980525022
Manufacturer Phone4253079233
Manufacturer G1ENDOGASTRIC SOLUTIONS, INC.
Manufacturer Street18109 NE 76TH STREET SUITE 100
Manufacturer CityREDMOND WA 980525022
Manufacturer CountryUS
Manufacturer Postal Code980525022
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameESOPHYX2 HD
Generic NameODE
Product CodeODE
Date Received2017-05-23
Returned To Mfg2017-05-02
Model NumberC02042-01
Catalog NumberR2005
Lot Number402355
Device Expiration Date2018-10-18
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerENDOGASTRIC SOLUTIONS, INC.
Manufacturer Address18109 NE 76TH STREET SUITE 100 REDMOND WA 980525022 US 980525022


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-23

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