FDRClass II
Sphyncteroscope
Gastroenterology, Urology · 21 CFR 876.1500
MDR events302All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
302 adverse event reports on file
- SINGLE USE 3-LUMEN SPHINCTEROTOMEDec 3, 2015MalfunctionOlympus Medical System Corporation2951238-2015-00592
- UTS PRECURVED ULTRA TAPER SPHINCTEROTOMEJul 17, 2015MalfunctionWilson-cook Medical Inc.1037905-2015-00298
- SINGLE USE 3-LUMEN SPHINCTEROTOMEJun 11, 2015MalfunctionOlympus Medical Systems Corp.8010047-2015-00430
- SINGLE USE 3-LUMEN SPHINCTEROTOMEJun 3, 2015InjuryOlympus Medical Systems Corp.8010047-2015-00386
- SINGLE USE 3-LUMEN SPHINCTEROTOMEJun 3, 2015MalfunctionOlympus Medical Systems Corporation8010047-2015-00427
- SINGLE USE 3-LUMEN SPHINCTEROTOMEMay 19, 2015MalfunctionOlympus Medical Systems Corporation8010047-2015-00354
- SINGLE USE 3-LUMEN SPHINCTEROTOMEOct 8, 2014MalfunctionOlympus Medical Systems Corp.8010047-2014-00628
- SINGLE USE 3-LUMEN SPHINCTEROTOMEOct 1, 2014MalfunctionOlympus Medical Systems Corporation8010047-2014-00551
- SINGLE USE 3-LUMEN SPHINCTEROTOMESep 22, 2014MalfunctionOlympus Medical Systems Corporation8010047-2014-00555
- SINGLE USE 3-LUMEN SPHINCTEROTOMESep 16, 2014MalfunctionOlympus Medical Systems Corporation8010047-2014-00534
Event type breakdown
Malfunction259
Injury30
Other8
Unspecified4
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.