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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SARL CAMERA HEAD AC - C-MOUNT; ENDOSCOPIC VIDEO CAMERA Back to Search Results
Model Number 242401
Device Problems Display or Visual Feedback Problem (1184); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Manufacturer Narrative
Fe minor scratches on the device.This device deemed non-repairable and will be placed into long term hold."faulty parts" was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation was not required as the reported event was not associated with the manufacturing process and/or the potential cause of the defect could not be associated to manufacturing.At this point in time, no corrective action was required, and no further action was warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint was observed in the field.
 
Event Description
It was reported by the sales rep that during returning inspection, it was observed that the controls on the camera head ac - c-mount device were functioning sporadically and the picture was going to red lines.During in-house engineering evaluation, it was determined that the device had intermittent loss of image and displayed intermittent red lines.There was no procedure nor patient involvement reported.No additional information was provided.
 
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Brand Name
CAMERA HEAD AC - C-MOUNT
Type of Device
ENDOSCOPIC VIDEO CAMERA
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ  CH-2400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle MA CH-24 00
SZ   CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key11876507
MDR Text Key255139325
Report Number1221934-2021-01645
Device Sequence Number1
Product Code FWF
UDI-Device Identifier10886705028733
UDI-Public10886705028733
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 company representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number242401
Device Catalogue Number242401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Initial Date Manufacturer Received 05/25/2021
Initial Date FDA Received05/25/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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