COBRA 7326071Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207013748), received between Aug 12, 2020 and Sep 15, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO RW (B)(4) THAT ON (B)(6) 2020, AFTER THE PATIENT WAS SENT TO THE OPERATING ROOM AND WAS SUCCESSFULLY ANESTHETIZED AND READY FOR OPERATION, THE DOCTOR FOUND THAT THE FLEXIBLE URETEROSCOPE COULD NOT BE OPERATED NORMALLY, RESULTING IN THE FAILURE OF THE OPERATION. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538487 ↗
• InjuryAug 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE DEVICE WAS "INSERTED INTO PENIS AND WHILE INSIDE IT FELL APART. THEY HAD TO GO BACK IN AND RETRIEVE WHAT PARTS THEY COULD FIND. CAUSED DELAY AND POSSIBLE HARM TO PATIENT SINCE THEY DON'T KNOW IF THEY RETRIEVED ALL THE PARTS. RWR-6/1/20 NEW 12/12/16 THEY WERE USING A LASER DURING THE PROCEDURE. THE INITIAL REPORTER CALLED BACK LATER AND CONFIRMED THEY DIDN'T USE A LASER WHEN THIS WAS INSIDE THE PATIENT. THEY USED IT AFTERWARDS. THE INITIAL REPORTER ALSO REPORTED ON THE MEDWATCH QUESTIONNAIRE: POTENTIAL PATIENT HARM DUE TO BLACK COVERING AT THE SCOPE TIP SLOUGHING OFF INSIDE OF PATIENT'S URETER. SMALL BLACK PIECES RETRIEVED. SCOPE HANDED OFF STERILE FIELD TO SPD CNOIC. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? YES. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10397455 ↗