VC10 PUMP, 115V VC-10

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 2018-11-20 for VC10 PUMP, 115V VC-10 manufactured by Gyrus Acmi, Inc.

Event Text Entries

[128029685] The device was not returned to olympus for evaluation. The cause of reported event cannot be determined at this time. The vc-10 instruction manual warns users "do not apply excessive force while using the cannulas and f-sets. Excessive pushing, bending, or pulling could result in injury to the patient and/or breakage of the device. " as part of or investigation, olympus followed up with the user facility regarding the reported event and limited information was provided. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported complaint. If additional information becomes available, this report will be updated and supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10


[128029686] Olympus was informed that the user facility performed 21 dilation and curettage (d&c) procedures between (b)(6) 2017 to present. Of that, four patients developed intrauterine hematomas and presented to the emergency room for treatment. In addition, patient 1 and patient 2 experienced heavy bleeding, patient 3 experienced pain with cramping and patient 4 developed a hematometrium. All four patients were managed under outpatient care. This is 4 of 4 reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2018-00712
MDR Report Key8091946
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-11-20
Date of Report2018-11-20
Date Mfgr Received2018-11-04
Date Added to Maude2018-11-20
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 ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVC10 PUMP, 115V
Generic NameVC10 PUMP
Product CodeHHI
Date Received2018-11-20
Model NumberVC-10
Catalog NumberVC-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer Address136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-11-20

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