Olympus A37025ARecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04042761023214), received between Dec 27, 2022 and Apr 13, 2026 — classified as 4 deaths, 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID CYSTOSCOPE EXHIBITED CHIPPED DISTAL END COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857854 ↗
• MalfunctionFeb 24, 2026Unstable

  IT WAS OBSERVED DURING DEVICE EVALUATION, THE COLOR RING OF THE RIGID CYSTOSCOPE WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436589 ↗
• MalfunctionOct 16, 2025Leak/Splash; Poor Quality Image; Leak/Splash; Poor Quality Image

  IT WAS REPORTED THE SUBJECT DEVICE HAD AIR LEAKAGE AND WATER LEAKAGE FROM LENS, RESULTED IN AN UNCLEAR FIELD OF VIEW, MAKING IT IMPOSSIBLE TO CONTINUE THE SURGERY. TWO SCOPES USED MENTIONING BOTH FAILURES AND ELECTRODE WHICH ARE A CONCOMITANT DEVICES. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312747 ↗
• MalfunctionAug 11, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772458 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿THE EFFECT OF ENDOSCOPIC RENAL AND URETERAL STONE SURGERIES ON RENAL BLOOD FLOW IN CHILDREN: A PROSPECTIVE TRIAL¿. LITERATURE SUMMARY AIM: TO ASSESS THE IMPACT OF ENDOSCOPIC STONE SURGERIES ON RENAL PERFUSION AND BLOOD FLOW IN CHILDREN. MATERIALS AND METHODS: CHILDREN WHO UNDERWENT PERCUTANEOUS NEPHROLITHOTOMY (PCNL), RETROGRADE INTRARENAL SURGERY (RIRS), URETERORENOSCOPY (URS), ENDOSCOPIC COMBINED INTRARENAL SURGERY (ECIRS) WERE INCLUDED TO THE STUDY. RENAL DOPPLER ULTRASONOGRAPHY (RDUS) WAS PERFORMED ONE DAY BEFORE THE OPERATION, AND ON THE POSTOPERATIVE 1ST DAY AND 1ST MONTH. PEAK SYSTOLIC VELOCITY (PSV) AND END-DIASTOLIC VELOCITY (EDV) WERE MEASURED, AND RESISTIVE INDEX (RI) WAS CALCULATED WITH THE (PSV-EDV)/PSV FORMULA. RDUS PARAMETERS WERE COMPARED BEFORE AND AFTER SURGERY AND BETWEEN IPSILATERAL AND CONTRALATERAL KIDNEYS. RESULTS: A TOTAL OF 45 CHILDREN WITH A MEDIAN AGE WAS 8 (2¿17) YEARS WERE INCLUDED (15 (33.3%) GIRLS, 30 (66.7%) BOYS). PCNL WAS PERFORMED IN 13 CHILDREN (28.9%), RIRS 11 (24.4%), URS 12 (26.7%), AND ECIRS 9 (20%). THERE WAS NO SIGNIFICANT DIFFERENCE IN RENAL AND SEGMENTAL PSV, EDV AND RI VALUES OF OPERATED

  Patient problems: Anemia; Blood Protein Abnormal; Convulsion/Seizure

  MAUDE report 22294870 ↗
• DeathJun 6, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER INDICATING THAT THE PATIENT WAS RE-ADMITTED TO A DIFFERENT FACILITY FOR TREATMENT OF AN INFECTION. THE PATIENT SUBSEQUENTLY EXPIRED AT THAT FACILITY, AND IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. THE CUSTOMER INDICATED THAT THEY DID NOT CONSIDER THE PATIENT¿S DEATH TO BE RELATED TO THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Sepsis; Septic Shock; Ventilator Dependent

  MAUDE report 22161983 ↗
• DeathJun 6, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER INDICATING THAT THE PATIENT WAS RE-ADMITTED TO A DIFFERENT FACILITY FOR TREATMENT OF AN INFECTION. THE PATIENT SUBSEQUENTLY EXPIRED AT THAT FACILITY, AND IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. THE CUSTOMER INDICATED THAT THEY DID NOT CONSIDER THE PATIENT¿S DEATH TO BE RELATED TO THE DEVICE. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE FIELDS (B5 AND F9) AND ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Sepsis; Septic Shock; Ventilator Dependent

  MAUDE report 22161432 ↗
• MalfunctionMay 13, 2025Break; Melted; Break; Melted

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A CROOKED AND CRUSHED BODY, A BURNED DISTAL END, AND INSERTION TUBE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014141 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE EVALUATION, THE SUBJECT DEVICE EXHIBITED A DAMAGED STOPCOCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763365 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE HAVE A BROKEN TIP. THE ISSUE OCCURRED DURING A THERAPEUTIC UROLOGY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763584 ↗
• MalfunctionOct 10, 2024Break; Break

  IT WAS REPORTED THE TELESCOPE SHAFT BROKE OFF, TOTAL LOSS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418605 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OBJECTIVE LENS OF THE TELESCOPE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157368 ↗
• DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION REGARDING THE EVENT AND DEVICE WAS RECEIVED BY THE CUSTOMER: 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

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

  MAUDE report 18997063 ↗
• DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION REGARDING THE EVENT AND DEVICE WAS RECEIVED BY THE CUSTOMER: 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

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

  MAUDE report 18995824 ↗
• MalfunctionSep 11, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE OP TELESCOPE, HAD A CRACKED EYEPIECE. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17717185 ↗
• MalfunctionFeb 22, 2023Material Twisted/Bent; Material Twisted/Bent

  A USER FACILITY REPORTED TO OLYMPUS THAT THE SCOPE WAS BENT. THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INJURY OR HARM, ASSOCIATED WITH THE EVENT, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16423255 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED ABOUT A LITERATURE STUDY THAT WAS CONDUCTED TO PREDICT STONE FREE RATE AND COMPLICATION RATE FOLLOWING MINI-PERCUTANEOUS NEPHROLITHOTOMY (M-PCNL) USING THE STONE NEPHROLITHOMETRY SCORE IN 106 PATIENTS. THE FOLLOWING PATIENT IMPAIRMENT WAS RECORDED IN THE COURSE OF THIS STUDY: [MODIFIED CLAVIEN GRADING GRADE I]. BLEEDING MANAGED WITH SINGLE EPISODE OF NEPHROSTOMY CLAMP - 7 PATIENTS. POST-OPERATIVE PAIN MANAGED WITH OPIOID ANALGESICS - 5 PATIENTS. POST-OPERATIVE FEVER MANAGED WITHOUT CHANGE IN ANTIBIOTICS - 1 PATIENT. DERANGED RENAL FUNCTION MANAGED WITH IV FLUIDS ONLY - 1 PATIENT. [MODIFIED CLAVIEN GRADING-GRADE II]. POST-OPERATIVE FEVER MANAGED WITH CHANGE IN ANTIBIOTICS - 6 PATIENTS . CULTURE-POSITIVE URINARY TRACT INFECTION - 1 PATIENT. [MODIFIED CLAVIEN GRADING-GRADE III A]. BLEEDING MANAGED WITH MULTIPLE BLADDER IRRIGATION/WASHOUT - 3 PATIENTS. BLEEDING REQUIRING MULTIPLE EPISODES OF NEPHROSTOMY CLAMP>4 H APART - 1 PATIENT. PNEUMOTHORAX MANAGED WITH INTERCOSTAL DRAINAGE - 1 PATIENT. HOWEVER, THERE WAS NO REPORT ABOUT A MALFUNCTION OF AN OLYMPUS DEVICE AND NO CONNECTION OF AN OLYMPUS DEVICE TO AN ADVERSE EVENT WAS REPORTED IN THE LITERATURE. PLEASE NOTE THAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 16349583 ↗
• MalfunctionFeb 4, 2023Break; Break

  THE CUSTOMER ANGLED OCULAR OPERATIVE TELESCOPE WAS RETURNED TO THE OLYMPUS (OMSC) REPAIR CENTER FOR A REPORTED IMAGE PROBLEM, ¿HARD TO SEE¿, ¿FIELD OF VISION IS CLOUDY¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT AN UNSPECIFIED EVENT. UPON INSPECTING AND TESTING, THE METAL-PLATED PART OF THE DISTAL TIP OF THE SCOPE IS DAMAGED. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. THE CUSTOMER FURTHER REPORTED THE DEVICE WAS INSPECTED PRIOR TO PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE METAL-PLATED PART OF THE DISTAL TIP OF THE SCOPE IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301230 ↗
• MalfunctionJan 5, 2023Break; Break

  OLYMPUS (OMSC) WAS INFORMED THAT DURING AN UNSPECIFIED EVENT, THE CUSTOMER OES ANGLED OCULAR TELESCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR A REPORTED POOR IMAGE PROBLEM. HOWEVER, DURING THE REPAIR INSPECTION BROKEN OPTICAL LIGHT FIBERS WAS FOUND DUE TO A DAMAGED DISTAL TIP ON THE OUTER TUBE. NO DEATH INJURY OR INFECTION AND NO IMPACT TO PERSON OR OTHER WAS REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN COMPONENT ON THE OUTER TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16108727 ↗
• MalfunctionDec 27, 2022Break; Fracture; Material Fragmentation; Image Display Error/Artifact; Mechanical Problem; Break; Fracture; Material Fragmentation; Image Display Error/Artifact; Mechanical Problem

  A RIGID SCOPE WAS RETURNED TO OLYMPUS FOR REPAIR WITH A REPORTED "CLOUDY IMAGE". THERE IS NO INDICATION THAT THE REPORTED DAMAGE OCCURRED DURING A PROCEDURE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049981 ↗