V-CARE LARGE (37MM) CUP 60-6085-202A

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 2020-03-03 for V-CARE LARGE (37MM) CUP 60-6085-202A manufactured by Conmed Corporation.

Event Text Entries

[183314085] The report device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10


[183314086] The conmed representative reported on behalf of the facility that the 60-6085-202a, v-care large, malfunctioned during a procedure on (b)(6) 2020. The type of hysterectomy is unknown. The surgeon filled the balloon with saline instead of air per the ifu. The saline leaked from the balloon and deflation occurred. The balloon fell off. This happened with 2 devices. The procedure was completed using a 3rd v-care with no issues. There was no patient injury or impact reported. There was no delay of procedure reported. The nurse did state that she is aware that air needs to be used with the balloon and not saline. This report is being raised as device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1320894-2020-00056
MDR Report Key9780140
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2020-02-05
Date Mfgr Received2020-02-05
Device Manufacturer Date2019-11-04
Date Added to Maude2020-03-03
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 ContactMELANIE LANNON
Manufacturer Street11311 CONCEPT BOULEVARD
Manufacturer CityLARGO, FL
Manufacturer CountryUS
Manufacturer Phone3995209
Manufacturer G1CONMED CORPORATION
Manufacturer Street525 FRENCH ROAD
Manufacturer CityUTICA, NY
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameV-CARE LARGE (37MM) CUP
Generic NameUTERINE MANIPULATOR
Product CodeLKF
Date Received2020-03-03
Catalog Number60-6085-202A
Lot Number201911041
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONMED CORPORATION
Manufacturer Address525 FRENCH ROAD UTICA, NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-03

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