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

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.

• Brand Name: TCK1 HD CAMERA HEAD
• Type of Device: ENDOSCOPIC 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 Key: 8114904
• MDR Text Key: 128915915
• Report Number: 1221934-2018-55450
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705026258
• UDI-Public: 10886705026258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 242400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1