Flex-X / IMAGE 1 S 11278VSUARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551402603), received between Jun 22, 2017 and Dec 11, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 1, 2022Open, Classified

   Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

   Z-1070-2022 · Root cause: Under Investigation by firm · FDA record ↗

2. Apr 1, 2022Open, Classified

   Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

   Z-1069-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2018Device Damaged by Another Device; Device Damaged by Another Device

  PER MEDWATCH REPORT, MW5081358, RECEIVED ON 12/6/18. IT STATED PT FOR LEFT URETERAL CYSTOSCOPY WITH LASER LITHOTRIPSY FOR LARGE SYMPTOMATIC KIDNEY STONE. AFTER STONE FRAGMENTATION, THE SCOPE WAS WITHDRAWN AND REVEALED THE LEFT URETER HAD BEEN AVULSED AND THE DISTAL END OF THE URETER WAS ENTRAPPED IN THE EXPOSED METAL VERTEBRAE AT THE DISTAL END OF THE SCOPE. THE PATIENT WAS TAKEN FOR AN URGENT NEPHROSTOMY TUBE PLACEMENT. THE PATIENT WAS ADMITTED FOR STABILIZATION AND OBSERVATION. THE PATIENT WAS DISCHARGED TO HOME WITH FOLEY AND NEPHROSTOMY WITH PLAN FOR RECONSTRUCTIVE PROCEDURE IN THE FUTURE.

  Patient problems: Injury; Rupture

  MAUDE report 8152315 ↗
• MalfunctionJun 22, 2017Partial Blockage; Partial Blockage

  ALLEGEDLY, THE DOCTOR WAS PERFORMING A URETEROSCOPY WITH KIDNEY STONE REMOVAL ON PATIENT, WHEN HE ATTEMPTED TO INTRODUCE LASER FIBER; IT WOULDN'T PASS THROUGH THE CHANNEL AT FIRST. FINALLY, THEY WERE ABLE TO PASS IT THROUGH, AND A PIECE OF THE LASER FIBER BROKE OFF INTO THE KIDNEY. THEY USED A WIRE BASKET TO RETRIEVE BROKEN LASER FIBER PIECE AND COMPLETED THE CASE WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6661762 ↗