Olympus A37022ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761023207), received between May 8, 2024 and May 8, 2024 — classified as 2 deaths.

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

• DeathMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, THERE WAS NO FLOW OUT OF THE OUTER SHEATH RESULTING IN INCREASED INTRARENAL PRESSURE CAUSING COMPLICATIONS. WHEN AN OLYMPUS REPRESENTATIVE WAS ONSITE AT THE CUSTOMER, THEY WERE INFORMED THAT AFTER THE PCNL PROCEDURE THE PATIENT HAD ADDITIONAL SURGERIES AND ENDED UP PASSING AWAY. THE PATIENT WAS INITIALLY DIAGNOSED WITH A 4-CENTIMETER OBSTRUCTIVE LEFT PELVIC STAGHORN CALCULUS WITH CHRONIC HYDRONEPHROSIS AND RENAL CORTICAL THINNING WITH MULTIPLE NON-OBSTRUCTIVE LEFT RENAL CALYCEAL CALCULI. THE PATIENT HAD MARGINAL KIDNEY FUNCTION AT 20%. THE PATIENT DID NOT WANT TO LOSE HER KIDNEY. THE SURGEON DISCUSSED OPTIONS WITH THE PATIENT AND INFORMED HER THAT SHE WOULD LIKELY LOSE THE KIDNEY IN THE FUTURE, BUT THEY DECIDED "TO GIVE THIS PROCEDURE A TRY". ON (B)(6) 2024 THE PATIENT UNDERWENT A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE USING AN OLYMPUS MINI-PCNL TRAY WITH MINI NEPHROSCOPE. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS NOT ENOUGH OUTFLOW FROM THE WORKING SHEATH AND THERE WAS POOR VISUALIZATION. SEVERAL ATTEMPTS WERE MADE TO SWITCH THE IRRIGATION PORT AND TEST FOR POSSIBLE CONTINUOUS FLOW, BUT THEY

  Patient problems: Aneurysm; Ascites; Cardiac Arrest; Disseminated Intravascular Coagulation (DIC); Hemorrhage/Blood Loss/Bleeding; Hypoxia; Increased Intra-Peritoneal Volume (IIPV); Ischemia; Necrosis; Respiratory Failure; Rupture; Septic Shock; Thrombosis/Thrombus; Unspecified Kidney or Urinary Problem; Vascular Dissection

  MAUDE report 19273982 ↗
• DeathMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE, THERE WAS NO FLOW OUT OF THE OUTER SHEATH RESULTING IN INCREASED INTRARENAL PRESSURE CAUSING COMPLICATIONS. WHEN AN OLYMPUS REPRESENTATIVE WAS ONSITE AT THE CUSTOMER, THEY WERE INFORMED THAT AFTER THE PCNL PROCEDURE THE PATIENT HAD ADDITIONAL SURGERIES AND ENDED UP PASSING AWAY. THE PATIENT WAS INITIALLY DIAGNOSED WITH A 4-CENTIMETER OBSTRUCTIVE LEFT PELVIC STAGHORN CALCULUS WITH CHRONIC HYDRONEPHROSIS AND RENAL CORTICAL THINNING WITH MULTIPLE NON-OBSTRUCTIVE LEFT RENAL CALYCEAL CALCULI. THE PATIENT HAD MARGINAL KIDNEY FUNCTION AT 20%. THE PATIENT DID NOT WANT TO LOSE HER KIDNEY. THE SURGEON DISCUSSED OPTIONS WITH THE PATIENT AND INFORMED HER THAT SHE WOULD LIKELY LOSE THE KIDNEY IN THE FUTURE, BUT THEY DECIDED "TO GIVE THIS PROCEDURE A TRY". ON (B)(6) 2024 THE PATIENT UNDERWENT A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE USING AN OLYMPUS MINI-PCNL TRAY WITH MINI NEPHROSCOPE. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS NOT ENOUGH OUTFLOW FROM THE WORKING SHEATH AND THERE WAS POOR VISUALIZATION. SEVERAL ATTEMPTS WERE MADE TO SWITCH THE IRRIGATION PORT AND TEST FOR POSSIBLE CONTINUOUS FLOW, BUT THEY

  Patient problems: Aneurysm; Ascites; Cardiac Arrest; Disseminated Intravascular Coagulation (DIC); Hemorrhage/Blood Loss/Bleeding; Hypoxia; Increased Intra-Peritoneal Volume (IIPV); Ischemia; Necrosis; Respiratory Failure; Rupture; Septic Shock; Thrombosis/Thrombus; Unspecified Kidney or Urinary Problem; Vascular Dissection

  MAUDE report 19273979 ↗