Howell G22921Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002229211), received between Jul 22, 2016 and Jul 22, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 22, 2016Break; Material Separation; Break; Material Separation

  DURING A BIOPSY PROCEDURE, THE USER SELECTED A COOK HOWELL BILIARY INTRODUCER FOR THE BILE DUCT BIOPSY. ACCESSING THE PAPILLA WAS SAME AS A NORMAL ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), AND THE ENDOSCOPE POSITION HAD NO NOTABLE PROBLEM. THE BILE DUCT WAS STENOSED AT APPROXIMATELY THREE (3) CM FROM THE PAPILLA, BUT THE USER COULD PASS THE INTRODUCER THROUGH AND PERFORMED THE BIOPSY WITHOUT A NOTABLE PROBLEM. HOWEVER, THE USER NOTICED THE SIDE RAMP MARKER WAS DETACHED FROM THE INTRODUCER WHEN HE ATTEMPTED TO RETRIEVE THE INTRODUCER. HE USED A BALLOON CATHETER TO MOVE THE DROPPED SIDE RAMP MARKER TO THE COMMON BILE DUCT, AND THEN HE CAPTURED IT USING A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET AND SUCCESSFULLY TOOK IT OUT OF THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5815303 ↗