Wills Oglesby G05274Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002052741), received between Aug 23, 2017 and Aug 31, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionAug 31, 2017Packaging Problem; Packaging Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PRODUCT WAS PACKAGED WITH THE WIRE GUIDE INSERTED BACKWARDS, WITH THE HARD PORTION OF THE GUIDE COMING OUT FIRST RATHER THAN THE FLEXIBLE PORTION. THIS WAS NOTICED THROUGH THE PACKAGING AND THE PRODUCT WAS NEVER USED; ACCORDINGLY, THERE WAS NO PATIENT CONTACT AND THERE WERE NO ADVERSE EVENTS RESULTING FROM THIS ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6834886 ↗
• InjuryAug 23, 2017Packaging Problem; Packaging Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE WIRE GUIDE IN AN ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET WAS PLACED BACKWARDS IN THE SET WHEN PACKAGED. THIS WAS REPORTEDLY DISCOVERED WHEN THE NEEDLE WAS INSERTED PERCUTANEOUSLY INTO THE STOMACH, FOLLOWED BY THE GUIDEWIRE, AND THEN A 7 FRENCH DILATOR. THE GUIDEWIRE WAS THEN REMOVED, AND CONTRAST MEDIA WAS INJECTED INTO THE STOMACH. THIS SHOWED A PERFORATION OF THE STOMACH WALL, WHICH WAS THEN CONFIRMED VIA X-RAY IMAGING. UPON REMOVAL OF THE GUIDEWIRE BY THE OPERATOR, IT WAS DISCOVERED THAT THE STIFF END OF THE GUIDEWIRE HAD BEEN INSERTED FIRST, RATHER THAN THE FLOPPY TIP, WHICH WOULD HAVE BEEN EXPECTED. THE TRACT WAS THEN DILATED UP, AND A GASTROSTOMY TUBE WAS PLACED. THE OPERATOR CHECKED THE POSITION OF THE TUBE, AND THEN THE PATIENT WAS RETURNED TO THE WARD. THE PATIENT RESTRICTIONS FOR FOOD AND DRINK FOLLOWING SURGERY WERE EACH EXTENDED AN ADDITIONAL 24 HOURS.

  Patient problems: Perforation

  MAUDE report 6813758 ↗