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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); Unexpected Shutdown (4019)
Patient Problems Tissue Damage (2104); Not Applicable (3189)
Event Date 09/29/2017
Event Type  Injury  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). Investigation summary: the device was received at the service center, however the system was found to be irreparable. The camera head was found not be working, and a replacement camera head was sent. Given the information provided, we cannot discern a potential root cause for the reported failure. A review into the depuy synthes mitek complaints system revealed no other complaints for this serialized device with the product code that was released to distribution. At this point, 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 affiliate in (b)(6) that during laparoscopy, it was observed that the tck1 hd camera head device suddenly stopped working during the surgery. It was not reported if there was a delay in the surgical procedure or if a spare device was available for use. 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)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key8019212
MDR Text Key125639264
Report Number1221934-2018-55098
Device Sequence Number1
Product Code FWF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
242400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number242400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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