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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CAMERA HEAD AC - C-MOUNT ENDOSCOPIC VIDEO CAMERA

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MEDOS INTERNATIONAL SàRL CAMERA HEAD AC - C-MOUNT ENDOSCOPIC VIDEO CAMERA Back to Search Results
Catalog Number 242401
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (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 customer that the camera head ac c-mount didn't power up and the blue light didn't appear when plugged in. It was discovered pre-operatively. The case was completed by using another mitek device without any patient harm or delay. It was mentioned that no further information was provided. 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 NameCAMERA HEAD AC - C-MOUNT
Type of DeviceENDOSCOPIC VIDEO CAMERA
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key8175529
MDR Text Key131146881
Report Number1221934-2018-55726
Device Sequence Number1
Product Code FWF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number242401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
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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