TCK1 HD CAMERA HEAD 242400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-11 for TCK1 HD CAMERA HEAD 242400 manufactured by Medos International Sàrl.

Event Text Entries

[138380868] Product complaint : (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[138380869] It was reported by the affiliate that thetck1 hd camera head image is flickering intermittently and color bars are appearing. The event occurred pre-operatively. The intended procedure was a turp. There was no surgical delay or patient consequences. The existing camera was used to complete the procedure; an alternate product was readily available. No surgical intervention is planned.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2019-56601
MDR Report Key8407826
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-11
Date of Report2019-01-21
Date of Event2019-01-20
Date Mfgr Received2019-10-26
Date Added to Maude2019-03-11
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 Phone5089776860
Manufacturer G1MEDOS INT MITEK
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTCK1 HD CAMERA HEAD
Generic NameENDOSCOPIC VIDEO CAMERA
Product CodeFWF
Date Received2019-03-11
Returned To Mfg2019-01-28
Catalog Number242400
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-11

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