MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TCK1 HD CAMERA HEAD; ENDOSCOPIC VIDEO CAMERA

Catalog Number 242400

Device Problem Intermittent Continuity (1121)

Patient Problem No Code Available (3191)

Event Date 08/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).(b)(4).

Event Description

Doctor called to inform that in the middle of a surgery image was not getting displayed on the monitor.Invalid camera head error 0125&our laparoscopy set stopped working and doctor managed to complete the surgery by converting it into an open surgery.During a laparoscopy appendix surgery camera stopped relaying the image or video on to the attached monitor and displayed invalid camera head error 0125.Additional information provided by the affiliate reported there was not much of a surgical delay because the surgery was converted from a laparoscopy surgery to an open surgery.The affiliate also reported there were no patient consequences.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10: additional narrative: b1, b2, e1, d10.H6: patient code 3191 used to capture surgical intervention being required.H3, h6: investigation summary: the device was received and evaluated at the service center.The reported complaint by the customer was confirmed.It was found that the camera head was physically damaged.The damaged device was replaced as it was deemed not repairable.User mishandling is one possible cause which could have caused the physical damage to the device.However, given the information provided we cannot discern a definitive root cause for the same.No non-conformances were identified for this part (242400) - lot number (om02019) combination.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TCK1 HD CAMERA HEAD
• Type of Device: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8951490
• MDR Text Key: 160884821
• Report Number: 1221934-2019-58168
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705026258
• UDI-Public: 10886705026258
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• 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: 08/22/2019
• Date Manufacturer Received: 10/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention