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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 Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: udi: (b)(4). Investigation summary: the complaint device was received at the service center and evaluated. It was reported that the sheath was not fitting. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: intermittent / no video. Cord damaged. Minor scratches on the device. The device was however deemed non-repairable and was being placed into long term hold. The faulty parts was identified as the root cause for the device failure during the service evaluation. Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing. At this point in time, no corrective action is required, and no further action is 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 is observed in the field.
 
Event Description
It was reported by sales rep that during an unknown procedure on (b)(6) 2021, it was observed that the cord on the camera head ac - c-mount device was loose. During in-house engineering evaluation, it was observed that the device was working intermittently with no video. There were no adverse patient consequences reported. No additional information was provided.
 
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Brand NameCAMERA HEAD AC - C-MOUNT
Type of DeviceENDOSCOPIC 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 Key11819543
MDR Text Key259044427
Report Number1221934-2021-01533
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number242401
Device Catalogue Number242401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
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 Unkown

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