Shetty G07276Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002072763), received between Mar 1, 2016 and Feb 15, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2018Crack

  THE PEEL-AWAY SHEATH THAT CAME WITH THE SET WAS NOTED TO BE CRACKED. THEY USED A DIFFERENT INTRODUCER PEEL-AWAY AND COMPLETED THE PROCEDURE WITH THE REMAINDER OF THE INITIAL SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7273016 ↗
• MalfunctionFeb 15, 2018Detachment Of Device Component; Split

  THE DEVICE HAD BEEN IN SITU FOR 4 MONTHS IN A PATIENT WITH A PRE-EXISTING CONDITION OF GASTROPARESIS. THE TUBE WAS REPORTED TO HAVE SPLIT FROM END CAP TO SITE OF SKIN. WITH PRE-EXISTING CONDITION, THE TUBE WAS REPORTED TO HAVE SPLIT FROM END CAP TO SITE OF SKIN. ADDITIONAL INFORMATION PROVIDED THAT ANOTHER DEVICE (NOT COOK) WAS PLACED. THE TUBE HAD A SPLIT FROM THE PROXIMAL END TO ENTRY AT SKIN. IT WAS SUSPECTED THAT PATIENT HAS PULLED STRING HARD DELIBERATELY, DUE TO PSYCHOLOGICAL ISSUES. THE SPLIT STARTED FROM 1 CM FROM THE RED CAP TO THE SKIN. IT LOOKS LIKE THE STRING HAS BEEN PULLED THROUGH THE SPLIT. THE PATIENT WAS NOT FEEDING AT THE TIME AND AWAY FROM THE WARD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 7272996 ↗
• MalfunctionFeb 15, 2018Crack

  PRIOR TO PATIENT CONTACT, IT WAS NOTED THAT THE TIP OF THE DILATOR HAD A CRACK IN IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER NEW DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7272880 ↗
• InjuryMar 1, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  04FEB2016- THE FEMALE PATIENT REPORTED A STOMA SITE INFECTION. THE PATIENT REPORTED THAT SHE HAD BEEN ON TWO WEEK REGIMEN OF AUGMENTIN TWICE DAILY FOR HER STOMA INFECTION. SHE WAS NOT ABLE TO RECALL WHEN THE STOMA INFECTION STARTED. SHE REPORTED THAT IT WAS FOUND BY HER VISITING NURSE WHO NOTED YELLOW DISCHARGE FROM THE STOMA SITE WITH NO COLOR, NO REDNESS, NO PAIN, NO SWELLING AND NO FEVER. THE PATIENT REPORTED THAT THE DISCHARGE WAS GETTING BETTER. 05FEB2016- UPDATE RECEIVED FROM THE PHYSICIAN STATED THAT THIS WAS PLACED ON (B)(6) 2015.

  Patient problems: Unspecified Infection

  MAUDE report 5470851 ↗