Olympus A20912ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761020244), received between Oct 17, 2023 and Oct 17, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 17950767 ↗