Flex-X 11278AU1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551226438), received between Apr 7, 2017 and May 9, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 reports).

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1067-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2022Material Fragmentation; Improper or Incorrect Procedure or Method; Material Integrity Problem; Material Fragmentation; Improper or Incorrect Procedure or Method; Material Integrity Problem

  PER COPY OF MDR #MW5106633 RECEIVED VIA MAIL FROM THE FDA: WHILE USING FLEXIBLE URETEROSCOPE DURING A URETEROSCOPY DOCTOR VISUALIZED A FOREIGN OBJECT. IT WAS RETRIEVED AND WAS BLUE IN COLOR AND OBSERVED BY STAFF. IT WAS DETERMINED TO BE PART OF SCOPE. NO PATIENT HARM DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14339104 ↗
• InjuryMar 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PER COPY OF MDR #MW506891 RECEIVED VIA EMAIL FROM THE FDA: WHILE USING FLEXIBLE URETEROSCOPE THE URETER WAS TORN AND A URETERAL STENT HAS TO BE PLACED UNTIL TEAR HEALED.

  Patient problems: Rupture

  MAUDE report 13824598 ↗
• MalfunctionFeb 6, 2019Material Separation; Material Separation

  DURING A URETEROSCOPY PROCEDURE THE DISTAL WRAP OF THE SCOPE CAME APART INSIDE THE PATIENT'S BLADDER. THE BROKEN PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313098 ↗
• InjuryJul 21, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ALLEGEDLY, THE DOCTOR REPORTED THAT SHE WAS PERFORMING A URETEROSCOPY W/KIDNEY STONE REMOVAL ON A PATIENT AND WHEN SHE REMOVED THE SCOPE FROM THE PATIENT THE URETER WAS PUNCTURED AND TORN. DOCTOR WAS 3/4 OF THE WAY INTO THE CASE AND HAD TO ABORT THE CASE EARLY, SINCE PATIENT'S URETER WAS INJURED AND HER VIEW WAS OBSTRUCTED AS A RESULT OF THE PROTRUDED AND BUBBLED SHEATHING AT DISTAL END OF THE SCOPE. THEY WERE UNABLE TO PLACE A STENT AT THAT TIME. DOCTOR CONFIRMED THE INJURY ON (B)(6) 2017; WALL OF THE URETER WAS PUNCTURED AND TORN. THEY HAD TO INSERT A PERCUTANEOUS NEPHROSTOMY TUBE OR CATHETER INSIDE PATIENT'S KIDNEY TO DRAIN URINE AND INSERT A PERCUTANEOUS ANTIGRADE STENT. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2017 AND SCHEDULED TO COME BACK FOR A FOLLOW-UP ON (B)(6) 2017 TO HAVE NEPHROSTOMY TUBE REMOVED. DOCTOR WILL BE MONITORING PATIENT'S PROGRESS.

  Patient problems: Perforation

  MAUDE report 6734291 ↗
• MalfunctionApr 7, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ALLEGEDLY, THE HOSPITAL STATED THAT DURING A URETEROSCOPY PROCEDURE THE DOCTOR COULD NOT REMOVE SCOPE FROM PATIENT. THEY CUT THE SHAFT FROM THE HANDLE TO REMOVE SCOPE. THE PATIENT SUSTAINED A SMALL PERFORATION TO THE URETER AND A STENT WAS USED FOR AN EXTENDED PERIOD OF TIME. THE DOCTOR USED ANOTHER URETEROSCOPE TO COMPLETE PROCEDURE. THE DOCTOR STATES PATIENT CONDITION IS GOOD.

  Patient problems: Perforation

  MAUDE report 6474278 ↗