Olympus WA33036ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · OP-telescope, 30°, 4 mm channel · Class 2
Quick summary
This Olympus rigid nephroscope is an operating telescope used in kidney surgery. The 28 reports mostly describe physical damage found during inspection — cracked or broken scope tips, chipped ends, and detached caps — with no patient harm in most cases. Two injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04042761051866), received between Jun 19, 2020 and May 6, 2026 — classified as 2 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Break” (13 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.
Reports received per month
Most reported problems
Device problems
- Break13
- Crack5
- Adverse Event Without Identified Device or Use Problem2
- Component Missing2
- Detachment of Device or Device Component2
- Poor Quality Image2
- Defective Component1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Inflammation1
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED A LITTLE CHIP ON THE DISTAL END OF THE SCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25107908 ↗MalfunctionJan 5, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED DAMAGE AT THE EYE END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957854 ↗MalfunctionDec 30, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23922816 ↗MalfunctionNov 19, 2025Defective Component; Defective Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID NEPHROSCOPE EXHIBITED DAMAGE AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597951 ↗MalfunctionNov 6, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490135 ↗MalfunctionAug 29, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD COLLAR CAP BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921119 ↗MalfunctionApr 30, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21940422 ↗MalfunctionApr 18, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD LENS BROKE, THE RODS MAY BE BROKEN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21868154 ↗MalfunctionMar 28, 2025Crack; Crack
IT WAS REPORTED THAT THE RIGID SCOPE HAD A CRACK ON THE LENS, CAN SEE A HAIRLINE CRACK. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21724208 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE GLASS WHERE CONNECTING THE FIBER OPTIC BUNDLE WAS BROKEN. THE ISSUE WAS FOUND DURING THE MAINTENANCE OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21635250 ↗MalfunctionJan 7, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOUND DISTAL FIBER BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092981 ↗MalfunctionJan 3, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD MISSED THE LIGHT POST ATTACHMENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21069742 ↗MalfunctionJan 3, 2025Component Missing; Component Missing
IT WAS REPORTED THE LIGHT POST ATTACHMENT OF SUBJECT DEVICE WAS MISSING DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067338 ↗MalfunctionNov 25, 2024Crack; Crack
IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD THE LENS CRACKED. THE ISSUE WAS FOUND, DURING PREPARATION FOR USE. FOR AN UNSPECIFIED 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 20775510 ↗MalfunctionNov 22, 2024Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BROKEN SCOPE. THE ISSUE OCCURRED DURING RECEIPT OR UNPACKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759887 ↗MalfunctionOct 10, 2024Break; Break
IT WAS REPORTED THE RIGID NEPHROSCOPE HAD A BROKEN LENS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20415161 ↗MalfunctionSep 24, 2024Break; Break
IT WAS REPORTED THAT THE OP-TELESCOPE HAD BROKEN OFF COMPONENTS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296883 ↗MalfunctionApr 26, 2024Break; Break
IT WAS REPORTED, BY THE CUSTOMER, THE RIGID NEPHROSCOPE HAD A BLURRY IMAGE. THE EVENT WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. AN ONSITE INSPECTION REPORT WAS PROVIDED BY THE CUSTOMER THAT INDICATED THE LENSES WERE BROKEN AND THERE WAS DARKENING ON THE RIGHT SIDE OF THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19190477 ↗MalfunctionMar 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BLACK CAP DISCONNECTED FROM THE SUBJECT DEVICE. THE ISSUE OCCURRED DURING PREPARATION FOR USE OF AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009109 ↗MalfunctionMar 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE'S MISSING PART WAS A SMALL BLACK COVER. IT IS UNKNOWN WHEN THE ISSUE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18886107 ↗MalfunctionJan 2, 2024Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT THE OP-TELESCOPE, 30°, 4 MM CHANNEL HAD DAMAGE TO THE MOUTHPIECE OF THE TREATMENT INSTRUMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432613 ↗MalfunctionNov 2, 2023Crack; Poor Quality Image; Crack; Poor Quality Image
THE CUSTOMER REPORTED TO OLYMPUS THAT THE OP-TELESCOPE, 30°, 4 MM CHANNEL HAD THE LENS DETACHED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18060825 ↗MalfunctionMar 28, 2023Crack; Crack
THE CUSTOMER REPORTED TO OLYMPUS, THE OP-TELESCOPE HAD BROKEN/CRACKED OPTICS. THE ISSUE WAS FOUND DURING REPROCESSING FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16629958 ↗MalfunctionFeb 2, 2023Break; Break
OLYMPUS WAS INFORMED THAT THE CUSTOMER AUTOCLAVABLE OPERATIVE RIGID TELESCOPE ¿HAS A BROKEN ADAPTER IN THE BACK.¿ THE CUSTOMER REPORTED ISSUE WAS FOUND AT REPROCESSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16281736 ↗InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED LITERATURE TITLED "INTERVENTIONAL RADIOLOGY-OPERATED CHOLECYSTOSCOPY FOR THE MANAGEMENT OF SYMPTOMATIC CHOLELITHIASIS: APPROACH, TECHNICAL SUCCESS, SAFETY, AND CLINICAL OUTCOMES". THE OBJECTIVE OF THE STUDY WAS TO REPORT THE TECHNIQUE, COMPLICATIONS, AND CLINICAL OUTCOMES OF INTERVENTIONAL RADIOLOGY¿OPERATED CHOLECYSTOSCOPY WITH STONE REMOVAL FOR THE MANAGEMENT OF SYMPTOMATIC CHOLELITHIASIS. TEN (77%) MEN AND THREE (23%) WOMEN (MEAN AGE, 65 YEARS) WITH SYMPTOMATIC CHOLELITHIASIS UNDERWENT CHOLECYSTOSTOMY FOLLOWED BY INTERVENTIONAL RADIOLOGY¿OPERATED CHOLECYSTOSCOPY WITH STONE REMOVAL. MAJOR COMORBIDITIES PRECLUDING CHOLECYSTECTOMY INCLUDED PRIOR CARDIAC, PULMONARY, OR ABDOMINAL SURGERY; CIRRHOSIS; SEPSIS WITH HYPONATREMIA; SEIZURE DISORDER; DEVELOPMENTAL DELAY; AND CHOLECYSTODUODENAL FISTULA. CHOLECYSTOSTOMY ACCESS, TIME BETWEEN CHOLECYSTOSTOMY AND CHOLECYSTOSCOPY, ENDOSCOPIC AND FRAGMENTATION DEVICES USED, TECHNICAL SUCCESS, PROCEDURE TIME, FLUOROSCOPY TIME, COMPLICATIONS, LENGTH OF HOSPITAL STAY, TIME BETWEEN CHOLECYSTOSCOPY AND CHOLECYSTOSTOMY REMOVAL, FOLLOW-UP, AND ACUTE CHOLECYSTITIS RECURRENCE WERE RECORDED. THE STUDY CONCLUDED THAT INTERVENTIONAL R
Patient problems: Inflammation
MAUDE report 10390795 ↗
Other Kit, Nephroscope devices
- HALOGEN LIGHT SOURCE OLYMPUS CLK-4Olympus Medical Systems Corp. · Kit, nephroscope61 reports
- MIP Minimal Invasive PCNL 27840KAKarl Storz GmbH & Co. KG · Kit, nephroscope1 recall3 reports
- HALOGEN LIGHT SOURCE CLH-SCOlympus Medical Systems Corp. · Kit, nephroscope37 reports
- Olympus A37025AOLYMPUS Winter & Ibe GmbH · Kit, Nephroscope4 deaths20 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AOlympus Medical Systems Corp. · Kit, nephroscope9 reports
- n.a. 27290MKarl Storz GmbH & Co. KG · Kit, nephroscope4 reports
- n.a. 27290KKarl Storz GmbH & Co. KG · Kit, nephroscope4 reports
- PANOVIEW PLUS 8965401Richard Wolf GmbH · Kit, nephroscope2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.