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 2019-04-15 for OVB1 CAMERA CONTROL UNIT 242300 manufactured by Medos International Sarl.

Event Text Entries

[144986396] (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


[144986457] It was reported by the affiliate via email that tck1 hd camera head and ovb1 camera control unit are not working. Additional information provided by the affiliate reported a 10 minute surgical delay due to the reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2019-56843
MDR Report Key8514087
Report SourceFOREIGN,OTHER
Date Received2019-04-15
Date of Report2019-03-22
Date of Event2019-03-22
Date Mfgr Received2019-08-07
Date Added to Maude2019-04-15
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 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 CAMERA
Product CodeFWF
Date Received2019-04-15
Returned To Mfg2019-06-20
Catalog Number242300
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SARL
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-15

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