OVB1 CAMERA CONTROL UNIT 242300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-03-18 for OVB1 CAMERA CONTROL UNIT 242300 manufactured by Medos International Sarl.

Event Text Entries

[139111708] (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[139111709] It was reported by the affiliate via email that during the surgery by using ovb1 ccu and tck1 hd camera head, the camera stopped giving output on the screen. Additional information received form the affiliate reported that the procedure was cancelled because the camera did not work and an alternative device was not available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2019-56627
MDR Report Key8429719
Report SourceFOREIGN,OTHER
Date Received2019-03-18
Date of Report2019-02-18
Date of Event2019-02-18
Date Mfgr Received2019-03-30
Date Added to Maude2019-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1MEDOS INTERNATIONAL SARL
Manufacturer StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal Code02400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOVB1 CAMERA CONTROL UNIT
Generic NameENDOSCOPIC VIDEO IMAGE PROCESSOR
Product CodeFWF
Date Received2019-03-18
Catalog Number242300
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SARL
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-03-18

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