HOPKINS 27294AARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04048551233825), received between Nov 2, 2023 and Dec 22, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (4 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Poor Quality Image; Insufficient Device Problem Information; Poor Quality Image; Insufficient Device Problem Information

  ACCORDING TO THE INFORMATION RECEIVED, THE IMAGE WAS BLURRY. IN CONSEQUENCE THE SURGERY WAS RE-SCHEDULED. THUS, THE CASE WAS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 23865650 ↗
• InjuryDec 22, 2025Poor Quality Image; Poor Quality Image

  ACCORDING TO THE INFORMATION RECEIVED, THE IMAGE WAS BLURRY. IN CONSEQUENCE THE SURGERY WAS RE-SCHEDULED. THUS, THE CASE WAS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 23865584 ↗
• MalfunctionNov 26, 2025Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ROD LENS CAME OUT DURING THE SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659217 ↗
• InjuryAug 11, 2025Optical Problem; Insufficient Device Problem Information; Optical Problem; Insufficient Device Problem Information

  THE PATIENT PRESENTED FOR LEFT PCNL FOR RENAL PELVIS AND LOWER CALYX STONE. SURGERY WAS SCHEDULED FOR 1.5 TO 2 HOURS, THE SURGERY WAS PROLONGED FOR 1 HOUR. THE ISSUE OCCURRED INTRA-OPERATIVELY DURING THE STONE FRAGMENTATION. DUE TO THE BLURRED VISION, THE SURGEON WAS UNABLE TO FULLY REMOVE THE STONE. THE REMAINING STONE WILL BE ADDRESSED IN A FOLLOW-UP PCNL. PATIENT WILL REQUIRE A SECOND PCNL SURGERY TO REMOVE THE REMAINING STONE.

  Patient problems: Insufficient Information

  MAUDE report 22773434 ↗
• InjuryAug 11, 2025Optical Problem; Optical Problem

  IT WAS REPORTED THAT THE DEVICE SHOWS BLURRED VISION. ACCORDING TO THE INFORMATION RECEIVED, THE DURATION OF THE SURGICAL PROLONGATION WAS THEREFORE LONGER THAN 60 MINUTES AND THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. IN ADDITION, AN ADDITIONAL SURGICAL/MEDICAL OR DIAGNOSTICAL INTERVENTION WAS NECESSARY TO PREVENT FURTHER INJURY TO THE PATIENT AND AN ADDITIONAL OR PROLONGED HOSPITALIZATION WAS NECESSARY. THEREFORE, THE RISK TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IS NOT NEGLIGIBLE AND THE EVENT IS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 22773430 ↗
• MalfunctionJun 18, 2025Inadequate or Insufficient Training; Detachment of Device or Device Component; No Apparent Adverse Event; Inadequate or Insufficient Training; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THAT THE LENS CAME OUT FROM SCOPE DURING SURGERY. THE VISION DETERIORATED IMMEDIATELY THEREAFTER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287966 ↗
• InjuryApr 15, 2024Material Fragmentation; Optical Problem; Material Fragmentation; Optical Problem

  IT WAS REPORTED THAT "DURING PCNL SUDDEN LOSS OF VISION OCCURRED AND ALL LENS OF THE TELESCOPE FALL OUT." FURTHER RECEIVED INFORMATION INDICATES THAT THE PROCEDURE WAS PROLONGED BY MORE THAN 60 MINUTES AND COULD NOT BE COMPLETED SUCCESSFULLY. THE INFORMATION ALSO INDICATE THAT THE PROCEDURE HAD TO BE POSTPONED BY 2 DAYS AND ADDITIONAL/PROLONGED HOSPITALIZATION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 19105175 ↗
• InjuryApr 15, 2024Material Fragmentation; Optical Problem; Material Fragmentation; Optical Problem

  IT WAS REPORTED THAT "DURING PCNL SUDDEN LOSS OF VISION OCCURRED AND ALL LENS OF THE TELESCOPE FALL OUT." FURTHER RECEIVED INFORMATION INDICATES THAT THE PROCEDURE WAS PROLONGED BY MORE THAN 60 MINUTES AND COULD NOT BE COMPLETED SUCCESSFULLY. THE INFORMATION ALSO INDICATE THAT THE PROCEDURE HAD TO BE POSTPONED BY 2 DAYS AND ADDITIONAL/PROLONGED HOSPITALIZATION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 19105174 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED THAT DURING FIFTH SURGERY THE VISION GOT LOST. IT WAS FOUND THAT OBJECTIVE LENS DETACHED FROM TIP. THE PROCEDURE ABANDONED.

  Patient problems: Insufficient Information

  MAUDE report 18066539 ↗
• InjuryNov 2, 2023Break; Break

  IT WAS REPORTED THAT DURING FIFTH SURGERY THE VISION GOT LOST. IT WAS FOUND THAT OBJECTIVE LENS DETACHED FROM TIP. THE PROCEDURE ABANDONED.

  Patient problems: Insufficient Information

  MAUDE report 18060115 ↗