FDA.reportPublic FDA data

MAUDE MDR 50941441

MDR report key
50941441
Report number
3008040402-2026-00333
Event key
0
Event type
3
Date of event
2026-07-30
Date received
2026-09-30
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
1
Health professional
1
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
87401Single Use 3-Lumen Sphincterotome VSINGLE USE 2-LUMEN SPHINCTEROTOMEOlympus Vietnam Co. Ltd.KNSKD-V411M-0730NY
418192Single Use 3-Lumen Sphincterotome VSINGLE USE 2-LUMEN SPHINCTEROTOMEOlympus Vietnam Co. Ltd.KNSKD-V411M-0730NY

Patients#

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

Event Narratives#

No narrative records found.