Olympus A20972ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761020374), received between Jun 1, 2018 and Aug 25, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Peeled/Delaminated; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438008 ↗
• MalfunctionJul 10, 2026Component Missing; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE PIN AT THE DISTAL END WAS MISSING DISPLAYED DURING SET UP INVOLVING AN OLYMPUS WORKING INSERT, ALBARRAN, TWO WAYS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25784160 ↗
• MalfunctionJun 26, 2026Material Twisted/Bent

  IT WAS REPORTED THE ALBARRAN DEVICE TIP WAS BENT. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638246 ↗
• InjuryOct 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING INSERTION OF NON-OLYMPUS GUIDEWIRE FOR A URETERAL STENT PLACEMENT, THE GUIDEWIRE GETS CAUGHT INSIDE AND WAS DIFFICULT TO ADVANCE TO THE TIP. THE TIP OF THE GUIDEWIRE WAS PROBABLY CAUGHT IN THE MATING AREA BETWEEN THE SHEATH AND HEBEL BRIDGE, AS REPORTED. THE GUIDEWIRE, WHOSE TIP HAD BECOME BENT DUE TO A SNAG, WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS REPEATED SEVERAL TIMES TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED FOR ONE AND A HALF TO TWO TIMES THE NORMAL LENGTH (USUALLY ABOUT ONE HOUR). THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS EVENT REQUIRES THREE REPORTS. THE PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6)- (A20912A) CYSTOSCOPE SHEATH. (B)(6)- (A20914A) CYSTOSCOPE SHEATH. (B)(6)- (A20972A) ENDOSCOPE ASSEMBLY ADAPTOR. THIS REPORT IS FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952642 ↗
• InjuryAug 13, 2021Material Twisted/Bent; Material Twisted/Bent

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE ALBARRAN PERFORATED THE PATIENT'S URETHRA CAUSING A TEAR IN SEVERAL PLACES OF THE UROTHELIUM. THE ALBARRAN WAS TWISTED 90 DEGREES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 12317746 ↗
• InjuryJun 9, 2021Material Twisted/Bent; Material Twisted/Bent

  OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC URETERAL STENT PLACEMENT PROCEDURE, THE RAISING WIRE AT THE DISTAL END OF THE DEVICE GOT BENT AND COULD NO LONGER BE RETURNED TO 0 DEGREES. WHEN REMOVING THE DEVICE FOR REPLACEMENT, THE PATIENT¿S URETER WAS INJURED AND BLEEDING OCCURRED. HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE BUT THE PATIENT¿S HOSPITALIZATION WAS PROLONGED DUE TO THE INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11965268 ↗
• MalfunctionFeb 18, 2020Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT IT WAS NOTICED THAT THE ALBARRAN LEVER AT THE DISTAL END OF THE WORKING INSERT COULD NOT BE RAISED ANYMORE AND THAT ITS FIXING PIN WAS MISSING. IT IS UNKNOWN WHEN THE FIXING PIN FELL OFF AND WHETHER THE FIXING PIN POSSIBLY FELL INTO THE PATIENT¿S BODY CAVITY. HOWEVER, IT WAS SUSPECTED THAT IT WOULD HAVE BEEN FLUSHED OUT FROM THE PATIENT WITH IRRIGATION FLUID IF IT HAD DETACHED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9719712 ↗
• MalfunctionJun 1, 2018Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE AT AN UNKNOWN DATE, THE ALBARRAN LEVER AT THE DISTAL END OF THE WORKING INSERT BROKE OFF. IT IS UNKNOWN WHETHER A FRAGMENT FELL INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7559966 ↗