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 2018-11-30 for TCK1 HD CAMERA HEAD 242400 manufactured by Medos International Sàrl.

Event Text Entries

[128903846] If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[128903847] It was reported by the affiliate in (b)(6) that the tck1 hd camera head device was not sensing the control unit. According to the reporter, there was an out of box failure. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1221934-2018-55469
MDR Report Key8119856
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-11-30
Date of Report2018-10-25
Date of Event2018-01-01
Date Mfgr Received2018-12-14
Date Added to Maude2018-11-30
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 S RL
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 NameTCK1 HD CAMERA HEAD
Generic NameENDOSCOPIC VIDEO CAMERA
Product CodeFWF
Date Received2018-11-30
Returned To Mfg2018-12-04
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 2018-11-30

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