FDA.reportPublic FDA data

MAUDE MDR 8577730

MDR report key
8577730
Report number
1221934-2019-56986
Event key
0
Event type
3
Date of event
2019-04-05
Date received
2019-05-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OVB1 CAMERA CONTROL UNITEDNOSCOPIC VIDEO IMAGE PROCESSORMEDOS INTERNATIONAL SàRLFWF242300R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-030

Event Narratives#

N

Patient 1

IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (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 AFFILIATE IN (B)(6) VIA PHONE THAT DURING AN UNSPECIFIED ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE OVB1 CAMERA CONTROL UNIT STOPPED GIVING OUTPUT ON THE SCREEN WHILE IN USE WITH THE HD COUPLER, C-MOUNT 17MM. THE SURGERY WAS CANCELLED AS NO SPARE CAMERA WAS AVAILABLE. IT WAS REPORTED THAT THE SURGERY WAS RESCHEDULED FOR THE NEXT DAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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.