FDA.reportPublic FDA data

MAUDE MDR 8175529

MDR report key
8175529
Report number
1221934-2018-55726
Event key
0
Event type
3
Date of event
2018-12-07
Date received
2018-12-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
CHEMIN-BLANC 38 LE LOCLE 02400 SZ
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAMERA HEAD AC - C-MOUNTENDOSCOPIC VIDEO CAMERAMEDOS INTERNATIONAL SàRLFWF242401N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-180

Event Narratives#

N

Patient 1

IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

IT WAS REPORTED BY THE CUSTOMER THAT THE CAMERA HEAD AC C-MOUNT DIDN'T POWER UP AND THE BLUE LIGHT DIDN'T APPEAR WHEN PLUGGED IN. IT WAS DISCOVERED PRE-OPERATIVELY. THE CASE WAS COMPLETED BY USING ANOTHER MITEK DEVICE WITHOUT ANY PATIENT HARM OR DELAY. IT WAS MENTIONED THAT NO FURTHER INFORMATION WAS PROVIDED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.