Atlas Wire G32788Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002327887), received between Dec 19, 2017 and Dec 20, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• InjuryDec 20, 2017Separation Failure

  THE FOLLOWING INFORMATION WAS REPORTED: A 3 FRENCH, 4 WIRE BASKET WAS PLACED AROUND THE DISTAL ASPECT OF THE STONE DURING A URETEROSCOPY. THE STONE WAS ENGAGED AND SLIGHTLY DISLODGED INFERIORLY, BUT IT WAS CLEARLY IMPACTED AGAINST THE SIDE WALL OF THE URETER. AS A RESULT, THERE WAS AN ATTEMPT TO DISENGAGE THE STONE BASKET, BUT THE STONE BASKET FAILED AND WOULD NOT DISENGAGE. MULTIPLE ATTEMPTS AT DISENGAGEMENT WERE TRIED. THE MATTER OF RECOURSE WAS TO CUT THE STONE BASKET WIRE PROXIMAL TO THE CONTROL HANDLE. SEVERAL WIRES THAT NAVIGATED THE STONE WERE THEN SEQUENTIALLY CUT UNTIL THE BASKET DISENGAGED. DUE TO THE NECESSARY TENSION APPLIED TO THE STONE BASKET TO MANUALLY DISENGAGE IT IN THE ABOVE MENTIONED MANNER, THERE CLEARLY WAS SOME MILD TRAUMA TO THE URETERAL WALL AND MUCOSA. A RETROGRADE SHOWED SOME EXTRAVASATION. SEVERAL ATTEMPTS AT REPEAT GUIDEWIRE PLACEMENT UP THE URETER WERE UNSUCCESSFUL AND THE BLADDER WAS THEN DRAINED. THE DEVICE WAS FULLY REMOVED FROM THE PATIENT AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THE PATIENT WAS IN OPERATING ROOM UNDER GENERAL ANESTHESIA WHEN EVENT OCCURRED. BASED UPON THE INFORMATION RECEIVED, THERE WAS NO REPORT O

  Patient problems: Extravasation; No Code Available

  MAUDE report 7135689 ↗
• MalfunctionDec 19, 2017Detachment Of Device Component

  DURING A CYSTO HOLMIUM LASER STONE REMOVAL PROCEDURE, A PIECE OF THE BASKET CAME OFF. THE PIECE DID NOT DETACH INSIDE THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129345 ↗