PRODUCT CODE FDT
Duodenoscope And Accessories, Flexible/Rigid
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Monitor reported device problems. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
2,884Prior 90 days: 2,586Injury reports
42Source-classified event typeDeath reports
3Reported relationship is unverifiedReporting change
11.5%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 2,838. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
EVIS EXERA III DUODENOVIDEOSCOPE
Read FDA report 50518737 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Degraded; Material Separation
EVIS LUCERA DUODENOVIDEOSCOPE
Read FDA report 50519679 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Detachment of Device or Device Component; Failure to Clean Adequately
EVIS EXERA III DUODENOVIDEOSCOPE
Read FDA report 50520046 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Loss of or Failure to Bond; Degraded
EVIS EXERA III DUODENOVIDEOSCOPE
Read FDA report 50520337 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Failure to Clean Adequately
EVIS EXERA III DUODENOVIDEOSCOPE
Read FDA report 50520355 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Peeled/Delaminated
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.