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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA

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MEDOS INTERNATIONAL SàRL TCK1 HD CAMERA HEAD ENDOSCOPIC VIDEO CAMERA Back to Search Results
Catalog Number 242400
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2018
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 affiliate in (b)(6) that pre-surgery to an unspecified surgical procedure, it was observed that the camera head device was not getting detected on switching on the ccu and monitor. It was not reported if there was a delay in the surgical procedure. It was reported that a spare device was available for use. It was reported if the procedure was completed. It was not reported if there was a delay in the surgical procedure or if a spare device was available for use. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown but was noted to have occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Evaluation statement: the device was received at service center and evaluated. The complaint is confirmed. As per the service report it is checked and found the camera head is not sensed by ccu and complaint device is not repairable. The root cause for the reported problem is undetermined. No nonconformances were identified for this part number 242400, serial number (b)(4) combination. 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. (b)(4). Corrected data: date device returned to manufacturer.
 
Event Description
Additional information received from affiliate on 18november2018: the issues was detected pre-operatively on (b)(6) 2018. There was no procedure or patient impact.
 
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Brand NameTCK1 HD CAMERA HEAD
Type of DeviceENDOSCOPIC VIDEO CAMERA
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL S RL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8121413
MDR Text Key128944781
Report Number1221934-2018-55486
Device Sequence Number1
Product Code FWF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
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
Report Date 10/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
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 Manufacturer10/29/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2018
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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