Entuit G35563Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002355637), received between Aug 3, 2017 and Feb 15, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: Foreign Body In Patient; No Code Available; Purulent Discharge

  MAUDE report 11330206 ↗
• MalfunctionJul 26, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET WAS USED DURING A GASTROSTOMY IN AN UNKNOWN PATIENT. THE OPERATOR REPORTED THE NEEDLE WAS "BLUNT." IT WAS FURTHER REPORTED THAT THE STOMACH "EVADES, "BECAUSE THE NEEDLE IS TOO DULL." ANCHORS WERE SUCCESSFULLY PLACED DURING THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8833659 ↗
• InjuryApr 1, 2019Migration; Migration

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

  Patient problems: Inflammation; No Code Available

  MAUDE report 8469988 ↗
• InjuryJan 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT 10 DAYS FOLLOWING PLACEMENT OF THE ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET, THE PATIENT PRESENTED WITH PUS-CONTAINING AND NECROTIC WOUNDS, WHICH WERE LOCATED UNDER THE ANCHORS. THE PRODUCT ISSUE NECESSITATED THE DISINFECTION AND WOUND CARE MEASURES. THE CUSTOMER CONFIRMED THAT WHEN DEPLOYING THE ADJUSTABLE ANCHORS, SLIGHTLY LOOSENING THEM AFTER PLACEMENT AVOIDS THE PROBLEM OF NECROTIZING IRRITATION. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: Pressure Sore/Ulcer; Purulent Discharge

  MAUDE report 7219574 ↗
• InjuryAug 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT DEVELOPED "WOUNDS WITH PUS AND A NECROSIS TO THE SKIN UNDER THE ANCHORS" APPROXIMATELY 15 DAYS FOLLOWING PLACEMENT OF ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHORS FOR AN UNSPECIFIED INDICATION. THE CUSTOMER INDICATES THAT THE DEVICES ARE PLACED "SLIGHTLY LOOSENED" TO ATTEMPT TO AVOID NECROTIZING IRRITATION. CULTURE RESULTS AND SENSITIVITY ARE NOT KNOWN. THE ACTIONS TAKEN BY THE CLINICAL STAFF WERE NOT PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE PRODUCT INSERT WARNS THAT "GASTROPEXY SITE SHOULD BE CHECKED DAILY FOR EARLY SIGNS OF PRESSURE ULCERS, INCLUDING DISCOLORATION AND TENDERNESS AROUND THE GASTROPEXY SITE." THIS IS ONE OF THREE MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED THREE PATIENT EVENTS OCCURRING OVER A ONE MONTH TIME FRAME. REFERENCE MDR NUMBERS 1820334-2017-02730, AND 1820334-2017-02732 FOR ALL ASSOCIATED REPORTS.

  Patient problems: Necrosis; Purulent Discharge; Unspecified Infection

  MAUDE report 6824972 ↗
• InjuryAug 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE - DISINFECTION AND WOUND CARE.

  Patient problems: Necrosis; Purulent Discharge; Unspecified Infection

  MAUDE report 6824958 ↗
• InjuryAug 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT DEVELOPED "WOUNDS WITH PUS AND A NECROSIS TO THE SKIN UNDER THE ANCHORS" APPROXIMATELY 15 DAYS FOLLOWING PLACEMENT OF ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHORS FOR AN UNSPECIFIED INDICATION. THE CUSTOMER INDICATES THAT THE DEVICES ARE PLACED "SLIGHTLY LOOSENED" TO ATTEMPT TO AVOID NECROTIZING IRRITATION. CULTURE RESULTS AND SENSITIVITY ARE NOT KNOWN. THE ACTIONS TAKEN BY THE CLINICAL STAFF WERE NOT PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE PRODUCT INSERT WARNS THAT "GASTROPEXY SITE SHOULD BE CHECKED DAILY FOR EARLY SIGNS OF PRESSURE ULCERS, INCLUDING DISCOLORATION AND TENDERNESS AROUND THE GASTROPEXY SITE." THIS IS ONE OF THREE MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED THREE PATIENT EVENTS OCCURRING OVER A ONE MONTH TIME FRAME. REFERENCE MDR NUMBERS 1820334-2017-02732, AND 1820334-2017-02733 FOR ALL ASSOCIATED REPORTS.

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 6824917 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT DEVELOPED "WOUNDS WITH PUS AND A START OF NECROSIS TO THE SKIN" MORE THAN 10 DAYS FOLLOWING PLACEMENT OF ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHORS FOR AN UNSPECIFIED INDICATION. THE CUSTOMER INDICATES THAT THE DEVICES ARE PLACED "SLIGHTLY LOOSENED" TO ATTEMPT TO AVOID NECROTIZING IRRITATION. CULTURE RESULTS AND SENSITIVITY ARE NOT KNOWN. THE ACTIONS TAKEN BY THE CLINICAL STAFF WERE NOT PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE PRODUCT INSERT WARNS THAT "GASTROPEXY SITE SHOULD BE CHECKED DAILY FOR EARLY SIGNS OF PRESSURE ULCERS, INCLUDING DISCOLORATION AND TENDERNESS AROUND THE GASTROPEXY SITE." THIS IS ONE OF FOUR MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED FOUR PATIENT EVENT S OCCURRING OVER A ONE MONTH TIME FRAME. REFERENCE MDR NUMBERS 1820334-2017-02358, 1820334-2017-02359 AND 1820334-2017-02360 FOR ALL ASSOCIATED REPORTS.

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 6811680 ↗
• InjuryAug 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT ON CHEMOTHERAPY FOR AN UNSPECIFIED INDICATION UNDERWENT AN UNSPECIFIED GASTROINTESTINAL PROCEDURE USING AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET. THE PATIENT REPORTED DISCOMFORT TO THE CLINICAL STAFF AT AN UNKNOWN TIME FOLLOWING IMPLANTATION. THE NURSING STAFF RELEASED THE SUTURE ANCHORS AT A TIME MORE THAN 2 WEEKS POST INSERTION. THE CUSTOMER REPORTED THAT THE SITE OF THE SUTURE ANCHORS "BECAME RED AND FESTERY LOOKING AND POSSIBLY INFECTED." THE GENERAL PRACTITIONER EXAMINED THE SITE AND PROVIDED ANTIBIOTIC CREAM SINCE PATIENT IS HAVING CHEMOTHERAPY. NO CULTURES RESULTS OF THE SITE WERE PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Unspecified Infection

  MAUDE report 6763423 ↗