PRODUCT CODE FDS
Gastroscope 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
9,946Prior 90 days: 9,888Injury reports
9Source-classified event typeDeath reports
1Reported relationship is unverifiedReporting change
0.6%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 9,935. 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.
Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Erratic or Intermittent Display
Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Detachment of Device or Device Component
EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
Read FDA report 50515562 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Residue After Decontamination
EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
Read FDA report 50516008 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Failure to Advance
EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
Read FDA report 50516187 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Erratic or Intermittent Display; Communication or Transmission Problem
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.