VueOptic G25343Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002253438), received between May 2, 2017 and May 2, 2017 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED NEPHROURETEROSCOPY AND LASER LITHOTRIPSY PROCEDURES ON A PATIENT BY USING VUEOPTIC 150CM FIBER OPTIC BUNDLE AND FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH DEVICES TOGETHER. THE PHYSICIAN NOTICED AN INCOMPLETELY TREATED STONE DUE TO LIMITED MANEUVERABILITY AND FLEXION OF THE DEVICES. THE PHYSICIAN TRIED THE BASKET AND LASER COMBINATION BUT IT DID NOT WORK. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE. STENT AND ADDITIONAL STONE PROCEDURES WERE SCHEDULED FOR THIS PATIENT. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THIS MED WATCH REPORT IS FOR VUEOPTIC 150CM FIBER OPTIC BUNDLE. PLEASE SEE MDR # 1820334-2017-00890 FOR THE SECOND DEVICE (FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH) USED ON THIS PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6537415 ↗
• InjuryMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A DIAGNOSTIC URETEROSCOPY PROCEDURE ON A PATIENT BY USING FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH AND VUEOPTIC 150CM FIBER OPTIC BUNDLE DEVICES TOGETHER. DURING THE SHEATH ADVANCEMENT, THE PHYSICIAN NOTICED THE URETER WAS PERFORATED DUE TO LARGER OUTER LUMEN OF THE FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH AND LACK OF APPROPRIATE FLEXION. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE. A STENT AND REPEAT DIAGNOSTIC URS WAS SCHEDULED FOR THE PATIENT. THIS MED WATCH REPORT IS FOR VUEOPTIC 150CM FIBER OPTIC BUNDLE. PLEASE SEE MDR # 1820334-2017-00675 FOR THE SECOND DEVICE (FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH) USED ON THIS PATIENT.

  Patient problems: Perforation

  MAUDE report 6537391 ↗
• InjuryMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED NEPHROURETEROSCOPY AND LASER LITHOTRIPSY PROCEDURES ON A PATIENT BY USING FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH AND VUEOPTIC 150CM FIBER OPTIC BUNDLE DEVICES TOGETHER. DURING THE SHEATH ADVANCEMENT, THE PHYSICIAN NOTICED THE URETER WAS PERFORATED DUE TO LARGER OUTER LUMEN OF THE FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH AND LACK OF APPROPRIATE FLEXION. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE. A STENT AND ADDITIONAL STONE PROCEDURE WAS SCHEDULED FOR THE PATIENT. THIS MED WATCH REPORT IS FOR VUEOPTIC 150CM FIBER OPTIC BUNDLE. PLEASE SEE MDR # 1820334-2017-00809 FOR THE SECOND DEVICE (FLEXOR 180 DEFLECTING URETERAL ACCESS SHEATH) USED ON THIS PATIENT.

  Patient problems: Perforation

  MAUDE report 6537378 ↗