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

Model Number 242401

Device Problems Display or Visual Feedback Problem (1184); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

Fe minor scratches on the device.This device deemed non-repairable and will be placed into long term hold."faulty parts" was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation was not required as the reported event was not associated with the manufacturing process and/or the potential cause of the defect could not be associated to manufacturing.At this point in time, no corrective action was required, and no further action was 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 was observed in the field.

Event Description

It was reported by the sales rep that during returning inspection, it was observed that the controls on the camera head ac - c-mount device were functioning sporadically and the picture was going to red lines.During in-house engineering evaluation, it was determined that the device had intermittent loss of image and displayed intermittent red lines.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: CAMERA HEAD AC - C-MOUNT
• Type of Device: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle MA CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11876507
• MDR Text Key: 255139325
• Report Number: 1221934-2021-01645
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705028733
• UDI-Public: 10886705028733
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/05/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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