Entuit G35570Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002355705), received between Aug 31, 2016 and Apr 6, 2020 — classified as 3 injuries, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2020Material Frayed; Material Frayed

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9929577 ↗
• MalfunctionApr 6, 2020Material Frayed; Material Frayed

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9929525 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET WIRE WAS TOO LARGE FOR A CHILD. BEFORE PLACING THE GASTROINTESTINAL TUBE, THE WIRE WAS UNABLE TO BE REMOVED; THEREFORE, IT WAS REMOVED THROUGH ENDOSCOPY. THE REPORTED DEVICE IS INTENDED FOR ANCHORING THE ANTERIOR WALL OF THE STOMACH TO THE ABDOMINAL WALL PRIOR TO INTRODUCTION OF INTERVENTIONAL CATHETERS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAVE NOT BEEN MADE AVAILABLE. THE REPORTED DEVICE DID NOT MALFUNCTION; HOWEVER, THE SURGICAL PLAN WAS ADJUSTED TO REMOVE THE WIRE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7497968 ↗
• MalfunctionNov 30, 2017Unraveled Material; Unraveled Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE BRAIDING OF THE ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR CAME APART AT THE PROXIMAL END OF THE DEVICE WHEN THE OPERATOR WAS TRYING TO ADVANCE THE WHITE TOGGLE DOWN THE SUTURE TO SECURE THE SUTURE ANCHOR IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO OTHER GASTROPEXY SUTURES THAT WERE CONTAINED IN THE SAME KIT. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AND NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE PRODUCT ISSUE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. AFTER FURTHER REVIEW OF THE RECORD, IT WAS DETERMINED THAT IT SHOULD BE NOTED THAT THE CUSTOMER REPORTED THAT, TO COMPLETE THE PROCEDURE SUCCESSFULLY, THE WHITE TOGGLE OF THE DEVICE WAS CUT AT THE SKIN SO THAT THE SUTURE COULD BE PASSED AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073109 ↗
• InjuryOct 13, 2016Sticking; Sticking

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6028210 ↗
• InjuryAug 31, 2016Difficult to Insert; Difficult To Position; Difficult to Insert; Difficult To Position

  DURING A PERCUTANEOUS GASTROSTOMY CASE ON A MALE PATIENT WITH PREEXISTING CONDITION OF LARYNX CANCER, THE DOCTOR IMPLANTED A GASTROSTOMY TUBE IN THE STOMACH (FOR NUTRITION) BEFORE THIS PLACEMENT. AT THIS TIME, THE DOCTOR REALIZED A GASTROPEXIE (GASTROPEXIE, IS ONE STEP OF THE PROCEDURE, DURING THIS TIME THE OBJECTIVE IS TO APPROACH STOMACH TO THE ABDOMINAL WALL, THE RADIOLOGIST USE THE ANCHOR SET FOR THAT WITH ANCHORAGE). THERE WAS BREAKAGE OF THE ANCHOR'S WIRE. THE WHITE PART OF THE ANCHOR WAS BLOCKED, SO IT WAS IMPOSSIBLE FOR THE RADIOLOGIST TO PLACE IT ON THE SKIN. IN THAT CASE IT AS IMPOSSIBLE TO PERFORM THE GASTROPEXIE WITH THE ANCHOR. THE RADIOLOGIST HAD TO CUT THE SUTURE AND USE ANOTHER ANCHOR SET. SUBSEQUENTLY, USING A PROBE FROM ANOTHER MANUFACTURER; WHICH DID NOT GO INTO THE COOK'S WIRE GUIDE. THERE WAS NO PROGRESSION OF THE PROBE INTO THE SHEATH INTRODUCER OF THE GASTROSTOMY. THERE WAS FAILURE OF PLACEMENT OF THE GASTROSTOMY, RESULTING IN SERIOUS "PNEUMOPERITOINE." THE OTHER MANUFACTURER'S PROBE IS NOT COMPATIBLE WITH THE COOK'S SHEATH INTRODUCER. A LARGER PROBE WAS NECESSARY FOR THE INTRODUCER. THE ANCHORAGE WAS NOT RETRIEVED AND LEFT TO PASS NATURALLY THROUGH THE SYSTE

  Patient problems: No Code Available

  MAUDE report 5917433 ↗