FTJClass II
Colonoscope, General & Plastic Surgery
Gastroenterology, Urology · 21 CFR 876.1500
MDR events224All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
224 adverse event reports on file
- HF UNIT "ESG-400"Jan 18, 2023MalfunctionOlympus Winter & Ibe Gmbh Berlin Facility9610773-2023-00263
- ADULT COLONOSCOPENov 9, 2016MalfunctionOlympus America, Inc.MW5065958
- EVIS EXERA COLONOVIDEOSCOPEMar 6, 2016InjuryOlympus Medical System Corporation2951238-2016-00177
- EVIS EXERA COLONOVIDEOSCOPEMar 6, 2016InjuryOlympus Medical System Corporation2951238-2016-00174
- EVIS EXERA COLONOVIDEOSCOPEMar 6, 2016InjuryOlympus Medical System Corporation2951238-2016-00178
- EVIS EXERA COLONOVIDEOSCOPEMar 4, 2016InjuryOlympus Medical System Corporation2951238-2016-00175
- EVIS EXERA COLONOVIDEOSCOPEMar 4, 2016InjuryOlympus Medical System Corporation2951238-2016-00176
- EVIS EXERA COLONOVIDEOSCOPEMar 4, 2016InjuryOlympus Medical System Corporation2951238-2016-00179
- TRI-EXNov 16, 2015MalfunctionCook Medical5224968
- OLYMPUS EVIS EXERA COLONOVIDEOSCOPEMay 18, 2012MalfunctionOlympus Medical Systems Corporation8010047-2012-00159
Event type breakdown
Malfunction165
Injury44
Other10
Unspecified3
Death2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.