n.a. 27026BORecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551074138), received between Apr 14, 2020 and Apr 17, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  "2ND CYSTOSCOPY SHEATH (TV05) USED ON PATIENT AND BROKE WHILST IN THE PATIENT - CONSULTANT TRIED TO REMOVE THE SHEATH +++ TIMES WITH FORCEPS, CATHETERS - USED RIGID AND FLEXIBLE APPROACH IN ORDER TO TRY AND REMOVE THE BROKEN FRAGMENT OF SHEATH". AND IN A FURTHER DESCRIPTION IT WAS STATED "SHEATH BROKE OFF AND CONSULTANT UNABLE TO REMOVE FRAGMENT FROM PATIENT DESPITE TRYING AMPLE TIMES. SHEATH STILL REMAINS IN PATIENT AND UNABLE TO COMPLETE PLANNED OPERATION SURGEON UNABLE TO REMOVE SHEATH FROM PATIENT, DESPITE TRYING, PATIENT HAS SINCE UNDERGONE A SECOND PROCEDURE TO REMOVE THE FRAGMENT WHICH HAS ALSO BEEN UNSUCCESSFUL. PATIENT WAS STABLE POST OP BUT HAD TO BE TRANSFERRED TO ANOTHER HOSPITAL FACILITY IN ORDER TO RECEIVE APPROPRIATE CARE SUCH AS POTENTIALLY NEEDED A SUPRAPUBIC CATHETER WHICH WE CANNOT PROVIDE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21856673 ↗
• InjuryApr 16, 2025Solder Joint Fracture; Detachment of Device or Device Component; Solder Joint Fracture; Detachment of Device or Device Component

  "2ND CYSTOSCOPY SHEATH (TV05) USED ON PATIENT AND BROKE WHILST IN THE PATIENT - CONSULTANT TRIED TO REMOVE THE SHEATH +++ TIMES WITH FORCEPS, CATHETERS - USED RIGID AND FLEXIBLE APPROACH IN ORDER TO TRY AND REMOVE THE BROKEN FRAGMENT OF SHEATH". AND IN A FURTHER DESCRIPTION IT WAS STATED "SHEATH BROKE OFF AND CONSULTANT UNABLE TO REMOVE FRAGMENT FROM PATIENT DESPITE TRYING AMPLE TIMES. SHEATH STILL REMAINS IN PATIENT AND UNABLE TO COMPLETE PLANNED OPERATION SURGEON UNABLE TO REMOVE SHEATH FROM PATIENT, DESPITE TRYING, PATIENT HAS SINCE UNDERGONE A SECOND PROCEDURE TO REMOVE THE FRAGMENT WHICH HAS ALSO BEEN UNSUCCESSFUL. PATIENT WAS STABLE POST OP BUT HAD TO BE TRANSFERRED TO ANOTHER HOSPITAL FACILITY IN ORDER TO RECEIVE APPROPRIATE CARE SUCH AS POTENTIALLY NEEDED A SUPRAPUBIC CATHETER WHICH WE CANNOT PROVIDE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21852769 ↗
• MalfunctionApr 14, 2020Material Separation; Material Separation

  AS PER A REPORT RECEIVED BY THE FACTORY IN (B)(6), THE TIP OF THE OBTURATOR BROKE INSIDE THE PATIENT AND FELL INTO THE BLADDER. TIP WAS RETRIEVED, AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9958926 ↗