Bush G16746Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002167469), received between Jun 28, 2016 and Apr 19, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Melted” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2018Melted; Smoking; Melted; Smoking

  IT WAS REPORTED THAT THE BUSH URETERAL ILLUMINATING CATHETER SET BEGAN SMOKING AND MELTED WHEN THE LIGHT SOURCE WAS CONNECTED. 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 Consequences Or Impact To Patient

  MAUDE report 7443450 ↗
• MalfunctionMay 25, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  THE REPORT INDICATED THAT: THE FACILITY WAS PERFORMING A ROUTINE REVIEW OF THEIR STOCK, AND DURING THIS TIME THEY NOTICED THIS PACKAGE HAD A GOOEY/SLIMEY SUBSTANCE ON THE INSIDE. IT COULD BE A TYPE OF LUBRICANT." IMAGES OF THE DEVICE CONFIRMED A CLEAR LIQUID TYPE SUBSTANCE WITHIN THE STERILE PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6591114 ↗
• MalfunctionMar 9, 2017Melted; Smoking; Melted; Smoking

  IT WAS REPORTED BY THE USER FACILITY THAT PRIOR TO PROCEDURE THE BUSH URETERAL ILLUMINATING CATHETER SET BEGAN TO SMOKE. THE DEVICE WAS PLUGGED INTO THE LIGHT SOURCE WHEN IT BEGAN TO HEAT UP. THE SMOKING OCCURRED AT THE PLUG CONNECTING TO THE LIGHT SOURCE AND THE DEVICE MELTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6390903 ↗
• MalfunctionJan 13, 2017Overheating of Device; Smoking; Overheating of Device; Smoking

  THE REPORTER ALLEGED THAT THE BUSH URETERAL ILLUMINATING CATHETER SMOKES WHEN IT IS CONNECTED TO THE XDP LUXTEC MODEL 9300. THERE WAS NO REPORT OF ANY PATIENT INJURY AS A RESULT OF THIS OCCURRENCE. ADDITIONAL INFORMATION REC'D 1/27/2017: USER FACILITY MEDSUN REPORT WAS RECEIVED PROVIDING EVENT DETAILS. THE EVENT DESCRIPTION INDICATES THAT THE DEVICE BEGAN TO SMOKE ABOUT 15 TO 20 SECONDS AFTER BEING PLUGGED INTO THE LIGHT SOURCE. SMOKE EMANATED FROM TWO HOLES WHERE THE DEVICE WAS PLUGGED INTO THE LIGHT SOURCE. A STAFF MEMBER REPORTS OBSERVING A BRIGHT RED CENTER WHERE THE DEVICE WAS PLUGGED. MEDSUN REPORT ATTACHED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY EACH DEVICE STATES UNDER THE PRECAUTIONS SECTION THAT " THE ANODIZED ALUMINUM PLUG CONDUCTS HEAT. ALLOW THE PLUG TO COOL DOWN PRIOR TO ATTEMPTING TO UNPLUG." THE INSTRUCTIONS FOR USE ALSO STATE UNDER THE INSTRUCTIONS FOR USE SECTION THAT: "NOTE: THIS CATHETER WILL NOT TRANSMIT THERMAL ENERGY ALONG ITS LIGHT FIBERS TO PATIENT TISSUE. ANY EXCESSIVE THERMAL DAMAGE FROM THE LIGHT SOURCE WILL MANIFEST AT THE CATHETER/LIGHT PLUG JUNCTION AND WILL NOT BE TRANSMITTED ALONG THE CATHETER LENGTH." "NOTE: HIGH-ENERGY LIGHT SOURCES SUCH AS XENON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6250700 ↗
• MalfunctionJan 13, 2017Overheating of Device; Overheating of Device

  IT IS ALLEGED THAT THE BUSH URETERAL ILLUMINATING CATHETER WAS UTILIZED VIA CYSTOSCOPY. THE ILLUMINATING CATHETER WAS PLACED DIRECTLY INTO THE INTEGRA LIGHT BOX AND OVERHEATED THE BLACK MATERIAL WHERE THE LIGHTED STENTS ARE INSERTED. THE CATHETERS WERE IMMEDIATELY REMOVED AND THERE WAS NO INTERVENTION REPORTED. 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 6250682 ↗
• MalfunctionJan 13, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BLACK CASING OF A BUSH URETERAL ILLUMINATING CATHETER SET MELTED AT THE JUNCTION OF THE STENT AND THE BLACK CASING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BUSH URETERAL ILLUMINATING CATHETER WAS UTILIZED WITH AN INTEGRA LIGHT SOURCE. 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 6250642 ↗
• MalfunctionAug 2, 2016Melted; Melted

  DURING A LAPAROSCOPIC COLECTOMY WITH CYSTOSCOPIC STENT PLACEMENT PROCEDURE, THE DEVICE STARTED TO MELT WHERE THE STENT ATTACHES TO THE BLACK CASING THAT CONNECTS TO THE LIGHT SOURCE. THIS WAS NOT NOTICED UNTIL THE PROCEDURE HAD BEEN COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5839561 ↗
• MalfunctionJun 28, 2016Melted; Overheating of Device; Melted; Overheating of Device

  DURING AN ENDOMETRIOSIS O A FEMALE PATIENT, AFTER THE CATHETERS HAD BEEN INSTALLED AND THE LIGHTSOURCE HAD BEEN ON FOR ONLY 5 MINUTES, THE CONNECTION BETWEEN THE LIGHTSOURCE PLUG AND THE CORD STARTED TO MELT. THE LIGHT IN THE CATHETERS WENT OUT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5755531 ↗