NaviPro™ M00556240Recalls & reported problems
Lake Region Medical · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08714729848257), received between Aug 11, 2020 and Aug 11, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2020Use of Device Problem; Use of Device Problem
DURING THE ERCP, THE PHYSICIAN CANNULATED THE BILE DUCT AND PLACED THE WIRE INTO THE BILE DUCT, AND ADVANCED IT UP INTO THE INTRAHEPATIC DUCTS. THE PHYSICIAN THEN EXCHANGED FOR A TANDEM XL CANNULA AND WAS ADVANCING THE CANNULA DOWN THE OLYMPUS 180 DUODENOSCOPE. HE REALIZED AT THE TIME THAT THE OLYMPUS SCOPE ELEVATOR BROKE DURING THIS PROCESS. HE BELIEVES THAT BECAUSE THE OLYMPUS ELEVATOR BROKE THAT AS HE WAS ADVANCING THE TANDEM CANNULA DOWN THE SCOPE, THE OLYMPUS ELEVATOR WAS NOT HOLDING THE WIRE IN PLACE, HOWEVER (UNBEKNOWNST AND UNWANTED BY THE PHYSICIAN) THE WIRE WAS ADVANCING DEEP INTO THE INTRAHEPATIC DUCTS WHILE HE WAS PASSING THE CANNULA. IT WAS BELIEVED THAT THE WIRE PUNCTURED THE LIVER CAPSULE AS A RESULT OF THE BROKEN OLYMPUS ELEVATOR NOT HOLDING THE WIRE IN PLACE, AS HE WAS ADVANCING THE CANNULA DOWN THE WORKING CHANNEL OF THE SCOPE. THE PHYSICIAN, ONCE NOTICING HOW THE WIRE MIGHT HAVE PUNCTURED THE LIVER CAPSULE, INJECTED CONTRACT TO COMPLETE A CHOLANGIOGRAM. CONTRAST EXTRAVAGATED OUTSIDE OF THE LIVER, PROVING THAT THE NAVIPRO WIRE PUNCTURED THE LIVER CAPSULE. AN ADVANIX PLASTIC STENT WAS PLACED TO RELIEVE THE OBSTRUCTION AND HELP THE BILE DUCT DECOMPRESS, ALSO AS AN A
Patient problems: Perforation
MAUDE report 10391384 ↗
Other Endoscopic Guidewire, Gastroenterology-Urology devices
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- Roadrunner G18154Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall18 reports
- Roadrunner G17542Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall9 reports
- Roadrunner G18153Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall6 reports
- Roadrunner G18155Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall3 reports
- Roadrunner G17539Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall2 reports
- Roadrunner G17540Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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