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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA

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MEDOS INTERNATIONAL SàRL TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA Back to Search Results
Catalog Number 242400
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand NameTCK1 HD CAMERA HEAD
Type of DeviceENDOSCOPIC VIDEO CAMERA
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL S RL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8119856
MDR Text Key128903846
Report Number1221934-2018-55469
Device Sequence Number1
Product Code FWF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number242400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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