n.a. 11272C1Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04048551226100), received between Oct 3, 2019 and May 7, 2026 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (3 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. 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-1061-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Use of Device Problem

  THE FOLLOWING WAS REPORTED: THE CUSTOMER HAS A FAULTY 11272C1 (LEAKING) CYSTO- URETHRO-FIBERSCOPE. APPARENTLY, TWO PATIENTS DEVELOPED A BLADDER INFECTION, WHICH LED TO THE DISCOVERY THAT THE ENDOSCOPE WAS LEAKING. DUE TO DEVELOPED BLADDER INFECTION THE EVENT IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117935 ↗
• InjuryMay 6, 2026Use of Device Problem

  THE FOLLOWING WAS REPORTED: THE CUSTOMER HAS A FAULTY 11272C1 (LEAKING) CYSTO-URETHRO-FIBERSCOPE. APPARENTLY, TWO PATIENTS DEVELOPED A BLADDER INFECTION, WHICH LED TO THE DISCOVERY THAT THE ENDOSCOPE WAS LEAKING. DUE TO DEVELOPED BLADDER INFECTION THE EVENT IS DEEMED REPORTABLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 25107407 ↗
• InjuryMar 23, 2026Microbial Contamination of Device

  ACCORDING TO THE CUSTOMER, SEVERAL PATIENTS REPORTED URINARY TRACT INFECTIONS AFTER TREATMENT. DESPITE PROPER DISINFECTION AND CORRECT REPROCESSING, THE CUSTOMER NOTED THAT THE DEVICE REPEATEDLY SHOWED MICROBIOLOGICAL ABNORMALITIES WITH EVIDENCE OF BACTERIAL CONTAMINATION. SINCE A DEVICE-RELATED INFECTION CANNOT BE EXCLUDED AND THE ISSUE HAS OCCURRED REPEATEDLY, THE EVENT IS DEEMED REPORTABLE. SINCE SEVERAL EVENTS WERE REPORTED, THE FOLLOWING THREE CASES WERE LINKED TO ONE ANOTHER: 20260004292; 20260004295; 20260004299.

  Patient problems: Urinary Tract Infection

  MAUDE report 24670877 ↗
• MalfunctionNov 14, 2025Fracture; Chemical Problem; Fracture; Chemical Problem

  IT WAS REPORTED THE SHEATH OF THE DEVICE BROKE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23553697 ↗
• MalfunctionNov 5, 2025Fracture; Chemical Problem; Fracture; Chemical Problem

  IT WAS REPORTED THE SHEATH OF THE DEVICE BROKE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23476375 ↗
• MalfunctionAug 26, 2025Optical Problem; Device Difficult to Maintain; Optical Problem; Device Difficult to Maintain

  IT WAS REPORTED THE IMAGE QUALITY OF THE FLEXIBLE SCOPE IS NOT CLEAR DURING SURGERY. IT IS NOT A BRAND NEW SCOPE AND IMAGE QUALITY IS BAD. DIFFICULTY IN DOING THE CYSTOSCOPY PROCEDURE. PROCEDURE COMPLETED SUCCESSFULLY. SPARE DEVICE WAS USED TO COMPLETE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900893 ↗
• InjuryAug 22, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FLEX IS LEAKING. BLADDER INJURY, UNNOTICED EMPTYING OF THE BLADDER.

  Patient problems: Bowel Perforation

  MAUDE report 22873171 ↗
• MalfunctionAug 5, 2025Fracture; Chemical Problem; Fracture; Chemical Problem

  IT WAS REPORTED THAT THE DEVICE SHOWS A BROKEN SHEATH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22717911 ↗
• InjuryDec 21, 2023Calcified; Material Invagination; Microbial Contamination of Device; Calcified; Material Invagination; Microbial Contamination of Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FRONT COVER OF THE PRODUCT (DEFECTIVE). INFECTIONS OCCURRED SEVERAL TIMES AFTER ENDOSCOPY. DUE TO THE REPORTED POSSIBLE INFECTIONS (CAUSALITY NOT CONFIRMED) THE RISK FOR SERIOUS DETERIORATION IN STATE OF HEALTH IS NOT NEGLIGIBLE.

  Patient problems: Insufficient Information

  MAUDE report 18378987 ↗
• InjuryDec 21, 2023Calcified; Calcified

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE FRONT COVER OF THE PRODUCT (DEFECTIVE). INFECTIONS OCCURRED SEVERAL TIMES AFTER ENDOSCOPY. DUE TO THE REPORTED POSSIBLE INFECTIONS (CAUSALITY NOT CONFIRMED) THE RISK FOR SERIOUS DETERIORATION IN STATE OF HEALTH IS NOT NEGLIGIBLE.

  Patient problems: Insufficient Information

  MAUDE report 18375032 ↗
• MalfunctionMay 10, 2023Contamination; Microbial Contamination of Device; Contamination; Microbial Contamination of Device

  THE EVENT OCCURRED IN GERMANY. THE CUSTOMER REPORTS A POSSIBLE INCIDENT DUE TO GERMS IN THE INSTRUMENT. NO DETAILS REGARDING MALFUNCTION, PATIENT INVOLVEMENT, OR NEGATIVE IMPACT ON THE STATE OF HEALTH WERE REPORTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THIS TIME. THUS, IN TERMS OF CAUTION, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 16904841 ↗
• MalfunctionMar 23, 2023Fire; Fire

  ADDITIONAL INFORMATION WAS PROVIDED THAT SMOKE WAS SEEN AT THE TOP OF THE WORKING SHAFT DURING ENDOSCOPIC SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599562 ↗
• MalfunctionApr 29, 2021Leak/Splash; Material Integrity Problem; Insufficient Device Problem Information; Leak/Splash; Material Integrity Problem; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): FROM (B)(6) 2021, HOSPITALIZATION OF 3 PATIENTS FOR KLEBSIALLA PNEUMONIAE EBSLE URINARY TRACT INFECTION. THIS REPORT IS FOR HOSPITALIZATION OF PATIENT 2 OF 3.

  Patient problems: Insufficient Information; Urinary Tract Infection

  MAUDE report 11744780 ↗
• MalfunctionApr 29, 2021Leak/Splash; Material Integrity Problem; Insufficient Device Problem Information; Leak/Splash; Material Integrity Problem; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): FROM (B)(6) 2021, HOSPITALIZATION OF 3 PATIENTS FOR KLEBSIALLA PNEUMONIAE EBSLE URINARY TRACT INFECTION. THIS REPORT IS FOR HOSPITALIZATION OF PATIENT #1 OF 3.

  Patient problems: Insufficient Information; Urinary Tract Infection

  MAUDE report 11744779 ↗
• MalfunctionApr 29, 2021Leak/Splash; Material Integrity Problem; Insufficient Device Problem Information; Leak/Splash; Material Integrity Problem; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): FROM (B)(6) 2021, HOSPITALIZATION OF 3 PATIENTS FOR KLEBSIALLA PNEUMONIAE EBSLE URINARY TRACT INFECTION. THIS REPORT IS FOR HOSPITALIZATION OF PATIENT 3 OF 3.

  Patient problems: Insufficient Information; Urinary Tract Infection

  MAUDE report 11744778 ↗
• MalfunctionOct 3, 2019Material Fragmentation

  PER THE CUSTOMER, DURING A ELECTIVE LEFT PERCUTANEOUS NEPHROLITHOTOMY, LEFT NEPHROSTOMY TUBE INSERTION, AND LEFT NEPHROSTOGRAM PROCEDURE, THE LEFT RENAL CALCULUS WAS EXTRACTED SUCCESSFULLY UTILIZING THE FLEXIBLE NEPHROSCOPE, AND THE LEFT NEPHROSTOGRAM DEMONSTRATES NO EXTRAVASATION. SURGEON OBSERVED BLACK PARTICLE DURING THE PROCEDURE, REALIZED THAT IT CAME FROM THE END OF THE FLEXIBLE CYSTOSCOPE. THEY WERE ABLE TO RETRIEVE IT AND THE PIECE MATCHED THE END OF THE FLEXIBLE CYSTOSCOPE. INSTRUMENT HAD BROKEN PIECES OF COATING ON THE TIP OF THE SCOPE. THE SCRUB TECH, THE SURGEON AND THE RN IN THE CASE EXAMINED THE SCOPE AND DECIDED THAT ALL PIECES HAD BEEN RETRIEVED. THE PATIENT TOLERATED THE PROCEDURE, AND WAS THEN TRANSFERRED TO A POST-ANESTHESIA CARE UNIT. PATIENT WAS STABLE AND WAS THEN DISCHARGED HOME.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 9152668 ↗