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Bush G16737Recalls & reported problems

Cook Incorporated · BUSH SL Ureteral Illuminating Catheter Set · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002167377), received between Nov 7, 2014 and Nov 7, 2014 — classified as 1 injury.

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

Device problems

  • Material Separation1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 7, 2014Material Separation

    DOCTOR STARTED SURGERY WITH CYSTOSCOPY FOR ENDOMETRIOSIS. DURING THE SURGERY DOCTOR DECIDED TO DO LAPAROSCOPY. LAPAROSCOPY WASN'T ENOUGH SO THEY MOVED TO LAPAROTOMY. AFTER LAPAROSCOPY THEY TOOK THE ILLUMINATING CATHETER OUT AND LEFT IT TO LIE ON TOP OF PATIENT'S LEG. THEY ALSO HAD TO MOVE THE POWER SOURCE TO MAKE MORE ROOM FOR THE NEXT PROCEDURE. THEY KEPT LIGHTS ON THE CATHETER AND AFTER A WHILE THEY NOTICED A SMELL LIKE SOMETHING WAS BURNING. AFTER SURGERY THEY NOTICED THAT THE ILLUMINATING CATHETER WAS BROKEN AND HAD BURNED THE COVERS UNDER THE CATHETER AND ALSO BURNED A SMALL MARK ON THE PATIENTS LEG. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: Burn(s)

    MAUDE report 4287597 ↗

Other Light, catheter, fiberoptic, glass, ureteral devices

All Light, catheter, fiberoptic, glass, ureteral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.