MAMBA VISION 7315001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207063460), received between Nov 8, 2021 and May 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (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.

• MalfunctionMay 26, 2022Failure to Disinfect; Failure to Clean Adequately; Failure to Disinfect; Failure to Clean Adequately

  IT WAS REPORTED TO RICHARD WOLF BY THE SALES REP THAT "THE UROLOGY GROUP IS CLAIMING FOUR PATIENTS HAVE RECENTLY GONE TO THE HOSPITAL WITH UTIS AFTER HAVING PROCEDURES WITH THIS MAMBA." ADDITIONAL INFORMATION: WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? NO. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? NO. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? YES. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NA. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NA. HOW WAS THE PATIENT ANESTHETIZED? UNKNOWN. ACCORDING TO AN EMAIL EXCHANGE BETWEEN THE COMPLAINTS SPECIALIST AND THE SALES REP, "THEY DIDN'T FILE A COMPLAINT WITH THE FDA. THEY (USER FACILITY), CANNOT CONFIRM THE SCOPE WAS THE ISSUE, BUT WANTED WOLF TO INVESTIGATE. THEY HAD THREE PATIENTS END UP WITH UTI'S. I IN-SERVICE THE STAFF AND SENT THE SCOPE TO WOLF FOR PRECAUTIONARY REASONS." ADDITIONAL EMAIL FROM THE ISA,: THE SALES REP WENT TO THE "ACCOUNT AND SHOWN THEM HOW TO BETTER CLEAN THE SCVOPE AND HE LEAK TESTED IT. IT DID PASS THE LEAK TEST, THE LEAD DOCTOR S

  Patient problems: Insufficient Information; Urinary Tract Infection

  MAUDE report 14516888 ↗
• MalfunctionNov 8, 2021Erratic or Intermittent Display; Unexpected Shutdown; Erratic or Intermittent Display; Unexpected Shutdown

  IT WAS REPORTED TO RICHARD WOLF: THE DEVICE WAS DELIVERED TO THE CUSTOMER ON (B)(6) 2021. THE FIRST TIME IT WAS USED THE PICTURE ON THE MONITOR WOULD FLICKER AND THEN EVENTUALLY SHUT OFF. THE SCOPE WAS WORKING WELL FOR THE FIRST FEW MINUTES AND THEN THE ISSUES STARTED HAPPENING. ADDITIONAL DETAILS: 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? NO. 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? UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO. THE FOLLOWING QUESTIONS WERE ASKED OF AND ANSWERED BY THE SALES REP REGARDING THE DELAY IN THE PROCEDURE: . HOW LONG WAS THE DELAY? LONG ENOUGH FOR THEM TO ABORT THE PROCEDURE. WHAT ACTIONS WERE BEING DONE DURING THE DELAY? THEY PULLED OUT THE PADDLE AND CLEANED IT AND RE INSERTED IT. DID THE PATIENT REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURES AS THE RESULT OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771606 ↗