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

Model Number 242401

Device Problem Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 udi: (b)(4)incomplete.

Event Description

Device report from synthes mitek reports an event in (b)(6) as follows: it was reported by the affiliate via cst that pre-operatively after the purevue system was switched on and the camera head ac - c-mount inserted, the system could not display a visual- merely horizontal, flickering stripes on black background were visible (and configuration instruction + image counter).After switching the processor (ccs) off and on again, also cleaning the camera connector with 70% alcohol wipes and dry off, the system was working again.This complaint is for one (1) camera head ac - c-mount.This report is 1 of 2 for (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected data: upon further review of this complaint it was found that it is a duplicate complaint.The product investigation will be captured under (b)(4).The affiliate confirmed that the device will be returned under (b)(4).Hence,investigation will be performed under (b)(4).Hence this complaint is a duplicate one and hence will be voided.Udi:(b)(4).The serial number is unknown.

• 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: 9199489
• MDR Text Key: 206784772
• Report Number: 1221934-2019-59037
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• 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?: No
• Date Manufacturer Received: 12/13/2019
• Patient Sequence Number: 1