Single Use 3-Lumen Sphincterotome V · SINGLE USE 2-LUMEN SPHINCTEROTOME
Olympus Vietnam Co. Ltd. · Material Twisted/Bent
- Manufacturer g1 address 2
- An Phuoc Commune
- Manufacturer contact t name
- Mr.
- Manufacturer contact state
- MA
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Dong Nai Province
- Manufacturer contact address 1
- 800 West Park Drive
- Manufacturer contact pcity
- +1(508)2
- Event type
- Malfunction
- Report number
- 3008040402-2026-00333
- Product problem flag
- Y
- Date received
- 20260930
- PMA pmn number
- K250945
- Date of event
- 20260730
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 01581
- Reporter occupation code
- PHYSICIAN
- Manufacturer contact plocal
- +1(508)207-7661
- Noe summarized
- 1
- Manufacturer contact l name
- Brill
- Manufacturer g1 postal code
- 810000
- Reporter country code
- FR
- Date added
- 20260930
- Manufacturer contact f name
- Todd
- Previous use code
- I
- Manufacturer contact country
- US
- Date changed
- 20260930
- Health professional
- Y
- Summary report flag
- N
- Manufacturer g1 zip code ext
- 0
- Date report
- 20260929
- Initial report to FDA
- Yes
- Manufacturer g1 country
- VM
- Manufacturer contact city
- Westborough
- MDR report key
- 50941441
- Date manufacturer received
- 20260903
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 81000
- Manufacturer g1 name
- Olympus Vietnam Co. Ltd.
- Adverse event flag
- N
- Single use flag
- Y
- Manufacturer g1 address 1
- 8 Street, Long Thanh Ind. Zone
- Manufacturer contact postal code
- 01581
- Type of report
- Initial submission
- Source type
- Foreign, Health Professional, User facility
- Device
- Device sequence number
- 87401
- Date received
- 20260930
- Brand name
- Single Use 3-Lumen Sphincterotome V
- Generic name
- SINGLE USE 2-LUMEN SPHINCTEROTOME
- Manufacturer d name
- Olympus Vietnam Co. Ltd.
- Manufacturer d address 1
- 8 Street, Long Thanh Ind. Zone
- Manufacturer d address 2
- An Phuoc Commune
- Manufacturer d city
- Dong Nai Province
- Manufacturer d zip code
- 81000
- Manufacturer d zip code ext
- 0
- Manufacturer d country
- VM
- Manufacturer d postal code
- 810000
- Device operator
- HEALTH PROFESSIONAL
- Model number
- KD-V411M-0730
- Device availability
- Yes
- Device report product code
- KNS
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- UDI di
- 04953170380594
- UDI public
- 04953170380594
- Harmonized identifiers (openFDA)
- Device name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.4300
- Device class
- 2
- Product problems
- Material Twisted/Bent
- Patient
- Patient sequence number
- 1
- Date received
- 20260930
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions