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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA

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DEPUY MITEK LLC US TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA Back to Search Results
Catalog Number 242400
Device Problems Intermittent Loss of Power (4016); Intermittent Energy Output (4025)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2017
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). Investigation summary: the device was sent to the service center for repair. Per service manual operational and diagnostic analysis confirmed reported issue of device not working correctly. The device would intermittently not display video when the cable was moved, and when pressing the "p" button would only intermittently respond. Device disassembled and decontaminated as per the service manual during initial evaluation. There is no repair authorized for this device, so the device will be placed into long term hold with no further repair activities taking place. No further investigation beyond what is noted will be conducted on this complaint. No further information regarding the cause of the defect has been provided to help determine a definitive root cause for this failure. This complaint can be confirmed. At this point in time, no corrective action is required, and no further action is warranted. However, depuy synthes 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 the sales rep that during set-up for an unspecified surgical procedure of the knee, it was observed that the visualization camera head 242400 device from mx-tck1 camera eval kit code 901286 was not working properly. According to the reporter, the device displayed an error message - possible loose connection when it was connected. During in-house engineering evaluation, it was determined that the device would intermittently not display video when the cable was moved; and would only intermittently respond when pressing the "p" button. There was no surgical delay. It was not reported if a spare device was available for use to complete the surgery successfully. There was patient involvement reported. There were no 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)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8114904
MDR Text Key128915915
Report Number1221934-2018-55450
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
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 Manufacturer10/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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