MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ALL-IN-ONE CCU+LIGHT ROW; ENDOSCOPIC VIDEO IMAGING SYSTEM

Model Number 242302

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.There was no allegation of malfunction against the device from the customer, defects were identified during service evaluation.Hence, this complaint can be confirmed.During the service evaluation the following defects were identified: mounting hardware - sdi connector.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/ or the potential cause of the defect cannot be associated to manufacturing.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.

Event Description

It was reported by the affiliate in (b)(6) that the all-in-one ccu+light row device had an unspecified malfunction.During in-house service and repair, it was determined that the mounting hardware - sdi connector was falling apart/ unattached on the device.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: ALL-IN-ONE CCU+LIGHT ROW
• Type of Device: ENDOSCOPIC VIDEO IMAGING SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 12967730
• MDR Text Key: 286954412
• Report Number: 1221934-2021-03659
• Device Sequence Number: 1
• Product Code: FCW
• UDI-Device Identifier: 10886705028702
• UDI-Public: 10886705028702
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242302
• Device Catalogue Number: 242302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Date Manufacturer Received: 12/08/2021
• 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