MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CAMERA HEAD AC - C-MOUNT; ENDOSCOPIC VIDEO CAMERA

Model Number 242401

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a mitek sales representative.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

It was reported that the purevue autoclavable camera head-c-mount would take pictures intermittently.They were able to complete the case by using the same camera head.This did not cause a surgical delay and there was no patient harm.This report is for a purevue autoclavable camera head-c-mount.This is report 1 of 1 for (b)(4).

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: device evaluated by mfr, device manufacture date, investigation summary- the complaint device was received at the service center and evaluated.It was reported that the unit was functioning intermittently.Per service manual operational and diagnostic, the reported failure was not confirmed.A manufacturing record evaluation was performed for the finished device 1902ce0643 number, and no non-conformances were identified.During evaluation, the reported issue cannot be duplicated.Additionally, no other fault was found.The testing of the unit was completed per the service manual, the unit passed all functional tests and is fully operational.The possible root cause for the reported failure cannot be determined.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Device history a manufacturing record evaluation was performed for the finished device 1902ce0643 number, and no non-conformances were identified.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: CAMERA HEAD AC - C-MOUNT
• Type of Device: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8955931
• MDR Text Key: 156606715
• Report Number: 1221934-2019-58176
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705028733
• UDI-Public: (01)10886705028733
• 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
• 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: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242401
• Device Catalogue Number: 242401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1