FDA.reportPublic FDA data

MAUDE MDR 50941430

MDR report key
50941430
Report number
3002808148-2026-34277
Event key
0
Event type
3
Date received
2026-09-30
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
401
Health professional
0
Initial report to FDA
1
Event location
0

Manufacturer Contact#

Contact
Mr. Todd Brill
Address
800 West Park Drive Westborough MA 01581 US
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
418184VISERA ELITE III VIDEO SYSTEM CENTERVIDEO SYSTEM CENTERSHIRAKAWA OLYMPUS CO., LTD.FETOTV-S700NY
443243VISERA ELITE III VIDEO SYSTEM CENTERVIDEO SYSTEM CENTERSHIRAKAWA OLYMPUS CO., LTD.FETOTV-S700NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-09-300

Event Narratives#

No narrative records found.