VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2R (REF N6005830)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 04953170411212), received between Oct 8, 2020 and Sep 24, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 reports).

5 other recalls cover devices cleared under the same FDA submission (K221683); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Residue After Decontamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892244 ↗
• MalfunctionSep 24, 2026Stretched; Material Deformation

  The videoscope was returned to the service center with a report of a cracked sheath. This does not indicate an MDR reportable event. However, MDR reportable failure was found during testing at the service center. During inspection of the device, it was found that the bending section cover had stretched and bunched up. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885131 ↗
• MalfunctionSep 8, 2026Detachment of Device or Device Component

  The customer returned the Cysto Nephro Videoscope for a separate issue. During the initial evaluation of returned device it was found the bending section cover/distal sheath is missing. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668377 ↗
• MalfunctionSep 1, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548810 ↗
• MalfunctionAug 21, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376103 ↗
• MalfunctionAug 12, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227786 ↗
• MalfunctionAug 10, 2026Degraded

  The customer returned the Cysto-Nephro Videoscope to the service center for evaluation related to a separate issue. During testing, the service repair technician identified rust was present around the objective lens. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197241 ↗
• MalfunctionJul 27, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025521 ↗
• MalfunctionJul 10, 2026Material Fragmentation

  THE CUSTOMER RETURNED THE CYSTONEPHROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE BENDING SECTION ADHESIVE WAS FOUND TO BE CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788602 ↗
• MalfunctionJun 26, 2026Corroded

  THE CUSTOMER RETURNED THE CYSTO-NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE BENDING SECTION WAS CORRODED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637463 ↗
• MalfunctionJun 19, 2026Microbial Contamination of Device

  THE CUSTOMER REPORTED THERE WAS FUZZ STUCK INSIDE OF AN OLYMPUS CYSTONEPHROVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563975 ↗
• MalfunctionMay 27, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE OBJECTIVE LENS HAD RUST AROUND THE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310860 ↗
• MalfunctionMay 27, 2026Mechanical Jam

  THE CUSTOMER REPORTED STUCK WITH THE LOCKING MECHANISM ON DURING INSPECTION FOR USE INVOLVING AN OLYMPUS CYSTO-NEPHRO VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310719 ↗
• MalfunctionMay 27, 2026Material Split, Cut or Torn

  THE VISERA CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A CHIPPED CHIPPED ADHESIVE AT THE OBJECTIVE LENS AND LIGHT GUIDE LENS WERE FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302835 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  THE VISERA CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A BLACK AND WHITE IMAGE WITH NO COLOR. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A CHIPPED BENDING SECTION COVER GLUE WAS FOUND TO BE MOST LIKELY DUE TO STRESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25295943 ↗
• MalfunctionMay 26, 2026Detachment of Device or Device Component

  THE CYSTO NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF SCOPE HAS NO COLOR ON THE IMAGE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, LENS GLUE IS MISSING WAS FOUND AT ESTIMATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279043 ↗
• MalfunctionMay 22, 2026Contamination

  THE VISERA CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A BLURRY IMAGE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, BLACK RESIDUE INSIDE THE OBJECTIVE LENS WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257954 ↗
• MalfunctionMay 22, 2026Crack; Material Twisted/Bent

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER FOR DAMAGE TO THE BENDING SECTION. WHICH IS NOT AN MDR REPORTABLE FAILURE. HOWEVER, MDR REPORTABLE FAILURES WERE FOUND DURING TESTING AT THE SERVICE CENTER. THE ADHESIVE WAS CHIPPED AT THE BENDING SECTION, ADHESIVE WAS CHIPPED AT THE OBJECTIVE LENS AND ADHESIVE WAS CHIPPED AT THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25251684 ↗
• MalfunctionMay 21, 2026Detachment of Device or Device Component

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FORGETTING TO PUT THE CAP ON AND THE END BLEW OUT. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CHIPPED BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250242 ↗
• MalfunctionMay 20, 2026Detachment of Device or Device Component

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A CRACK TOWARDS THE HANDLE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT, HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, MISSING/DETACHED ADHESIVE AT LIGHT GUIDE LENS AND DETACHED CHIPPED/DETACHED BENDING SECTION SHEATH ADHESIVE WAS FOUND, LIKELY DUE TO STRESS. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234744 ↗
• MalfunctionMay 20, 2026Material Split, Cut or Torn

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE VIDEO PICTURE WILL NOT COME IN THE SCREEN, THEN IT WILL SWITCH TO COLOR BARS THEN IT WILL COMPLETELY SHUT OFF. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CHIPPED ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234551 ↗
• MalfunctionMay 13, 2026Loss of or Failure to Bond

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BENDING SECTION COVER ADHESIVE OF THE CYSTONEPHROVIDEOSCOPE LIFTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161954 ↗
• MalfunctionMay 11, 2026Degraded

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE BENDING SECTION ADHESIVE WAS CHIPPED AND WAS FOUND TO BE MOST LIKELY DUE TO STRESS LED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136881 ↗
• MalfunctionMay 6, 2026Detachment of Device or Device Component

  THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST AND PUNCTION MARK BY A NEEDLE IN THE WORKING CHANNEL. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CHIPPED BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107338 ↗
• MalfunctionApr 24, 2026Contamination /Decontamination Problem

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED RESIDUE ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987087 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221683. One submission often covers many models, so check the product and lot details in each record.

• Z-0690-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
• Z-0689-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
• Z-0691-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
• Z-0692-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
• Z-0331-2024 · Sep 25, 2023 · Open, Classified
  Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.