FDA Adverse Event Malfunction Summary report: N

CAMERA HEAD AC - C-MOUNT

MDR report key: 11876507 · Received May 25, 2021

Report

Report Number: 1221934-2021-01645
Event Type: Malfunction
Date Received: May 25, 2021
Date of Event: April 8, 2021
Report Date: May 25, 2021
Manufacturer: MEDOS INTERNATIONAL SARL
Product Code: FWF
UDI-DI: 10886705028733
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
776866	CAMERA HEAD AC - C-MOUNT	ENDOSCOPIC VIDEO CAMERA	FWF	MEDOS INTERNATIONAL SARL	242401		10886705028733

Patients

Seq	Age	Sex	Outcome	Treatment
1