FDA Adverse Event Malfunction Summary report: N

CAMERA HEAD AC - C-MOUNT

MDR report key: 14194332 · Received April 25, 2022

Report

Report Number: 1221934-2022-01204
Event Type: Malfunction
Date Received: April 25, 2022
Manufacturer: MEDOS INTERNATIONAL SARL
Product Code: FWF
UDI-DI: 10886705028733
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CI
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL NARRATIVE: UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: FUNCTIONAL : INTERMITTENT OPERATION CABLE . THE REPAIR OF THE DEVICE WAS HOWEVER DECLINED AND WAS RETURNED TO THE CUSTOMER UNREPAIRED THE ROOT CAUSE FOR THE DEVICE FAILURE COULD NOT BE DETERMINED DURING THE SERVICE EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER (B)(4), AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

Description of Event or Problem · 0

IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE VIDEO ON THE CAMERA HEAD AC - C-MOUNT DEVICE WAS NOT WORKING WHEN THE CABLE WAS HANDLED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION IN THE CABLE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
689267	CAMERA HEAD AC - C-MOUNT	ENDOSCOPIC VIDEO CAMERA	FWF	MEDOS INTERNATIONAL SARL	242401		10886705028733

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown