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

Catalog Number 242400

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the affiliate that thetck1 hd camera head image is flickering intermittently and color bars are appearing.The event occurred pre-operatively.The intended procedure was a turp.There was no surgical delay or patient consequences.The existing camera was used to complete the procedure; an alternate product was readily available.No surgical intervention is planned.

Manufacturer Narrative

Product complaint (b)(4).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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary :the complaint device was received at the service center and evaluated.The complaint can be confirmed since the tck1 camera head was working as intended post firmware upgrade and burning test.We cannot discern a root cause for the reported failure mode.The unit passed all functional tests and is fully operational.A manufacturing record evaluation was performed for the finished device [product code: 242400, serial number: (b)(4).And no non-conformances were identified per qlik query.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.Udi:(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: corrected data: g4: alert date on initial medwatch report should have been january 21, 2019.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11: corrected data: g4: awareness date reported on follow up report 1 as january 21, 2019 but should have been march 11, 2019.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: 8407826
• MDR Text Key: 138380868
• Report Number: 1221934-2019-56601
• 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,Followup,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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: 01/28/2019
• Date Manufacturer Received: 10/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1