Endo Close 173022Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521051492), received between Jun 1, 2017 and Mar 26, 2026 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, THE SUTURE BROKE WAS THREADED THROUGH THE DEVICE AND INSERTED INTO THE ABDOMINAL WALL. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696603 ↗
• MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC MEDIAN ARCUATE LIGAMENT INCISION, THE ORGAN LIFTING WAS USED, BUT THE INNER AND OUTER TUBES WERE DETACHED. A NEW ENDO CLOSE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440193 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOT-SUPPORTED LAPAROSCOPIC DA VINCI RECTAL RESECTION, THE DEVICE WAS USED, BUT THE INNER AND OUTER TUBES WERE DETACHED. NO COMPONENT FELL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308716 ↗
• MalfunctionJul 17, 2024Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TEETH ON THE TIP DEVICE DAMAGED THE SUTURE AND THE GRASPER FRAYED THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760902 ↗
• MalfunctionApr 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE DEVICE WAS OPENED, THE TOP BUTTON CAME OFF EVEN THOUGH NO PARTICULAR FORCE WAS APPLIED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074248 ↗
• MalfunctionMar 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE TIP FELL DOWNWARD, AND THE DEFECTIVE PRODUCT COULD NOT BE CLAMPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18834080 ↗
• MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, DURING PRODUCT PREPARATION, THE GREEN ROUND PART AT HAND DAMAGED AND CAME OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18745298 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE GREEN PART ON THE TOP OF THE DEVICE WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459007 ↗
• MalfunctionDec 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN OPENED THE PACKAGE TO ATTEMPT TO USE THE DEVICE, THE INNER CYLINDER SLIPPED THROUGH AND FELL THROUGH, IT COULD NOT BE USED BECAUSE IT COULD NOT BE FIXATED. A NEW DEVICE OF THE SAME PRODUCT WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352159 ↗
• MalfunctionDec 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SHAFT INSIDE THE DEVICE DISENGAGED. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249026 ↗
• MalfunctionApr 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, WHEN PIERCING THE WALL TO INSERT THE SUTURE FROM THE ABDOMINAL WALL INTO THE ABDOMINAL CAVITY, THE GREEN BUTTON ON THE HEAD WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16737853 ↗
• MalfunctionFeb 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY FOR ESOPHAGEAL CANCER, THE UPPER PART BROKE AND CAME OFF. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433272 ↗
• MalfunctionAug 18, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, BEFORE USING ON THE PATIENT, THE BLUE GREEN PART ON THE HEAD OF THE DEVICE BROKE OFF WHEN TAKING OUT OF THE PACKAGE. TO RESOLVE THE ISSUE, A NEW DEVICE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251117 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY AIMED TO INVESTIGATE EARLY SAFETY AND EFFECTIVENESS OUTCOMES OF SLEEVE GASTRECTOMY WITH TRANSIT BIPARTITION THAT WAS PERFORMED BETWEEN DECEMBER 2015 AND DECEMBER 2019, 883 PATIENTS PARTICIPATED AND POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING, GASTRO-ILEAL ANASTOMOTIC STENOSIS AND PORT-SITE HERNIA . BLEEDING AND HERNIA REQUIRED REOPERATION FOR TREATMENT. STENOSIS REQUIRED BALLOON DILATATION OR REOPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hernia; Stenosis

  MAUDE report 14879694 ↗
• MalfunctionJan 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE IN A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHEN THE BUTTON WAS PRESSED TO EXPOSE THE TIP HOOK, THE BUTTON WAS DISENGAGED, SO USAGE WAS DISCONTINUED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156120 ↗
• MalfunctionDec 29, 2021Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS USED TO PULL THREAD DURING VENTRAL INCISIONAL HERNIA. WHEN TRYING TO PULL THE THREAD FROM THE ABDOMINAL CAVITY TO FIX THE MESH AND INSERTING THE DEVICE THROUGH THE SKIN, THE GREEN BUTTON AT HAND WAS PUSHED AND THE BUTTON PART CAME OFF. WHEN TRYING TO PULL OUT THE HOOK FROM THE STYLET AT THE TIP. SINCE THE BUTTON CAME OFF, THE DEVICE BECAME DIFFICULT TO PUSH IT IN. TO RESOLVE THE ISSUE,  A NEW PRODUCT WAS TAKEN OUT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112475 ↗
• MalfunctionApr 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE DEVICE WAS OPENED, THE HANDLE PART WAS FOUND TO HAVE COME OFF. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694682 ↗
• MalfunctionApr 6, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC TOTAL CYSTECTOMY, WHILE CLOSING THE SURGICAL INCISION, THE PATIENT'S ABDOMINAL WALL WAS SO THICK AND THE SURGEON HAD DIFFICULTY IN REMOVING THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619421 ↗
• MalfunctionFeb 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS GRAFT, WHEN THE PRODUCT WAS OPENED AND THE DEVICE WAS ATTEMPTED TO BE TAKEN OUT TO THE STERILE FIELD, THE GREEN PARTS ON THE TOP OF THE PRODUCT BROKE OFF AND JUMPED OUT OF THE SURGICAL FIELD. A NEW PRODUCT WAS OPENED TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300492 ↗
• MalfunctionFeb 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS FOUND BROKEN AFTER OPENING THE PACKAGE. THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9711271 ↗
• MalfunctionJul 11, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INCISIONAL HERNIA PROCEDURE, WHILE EXTRACTING THE NEEDLE FROM THE ABDOMEN, THAT PART THAT MAKE UP THE DEVICE SEPARATED, ONE CAME OUT OF THE ABDOMEN, THE OTHER NEEDLE FELL INSIDE THE PATIENT CAVITY, AFTER THAT THEY ALSO ABLE TO RETRIEVED THE SECOND PART FROM ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780514 ↗
• MalfunctionMay 10, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN USING THE DEVICE, THE TIP OF THE NEEDLE DISENGAGED, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW DEVICE WAS USED. NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601530 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE STUDY, IT SHOWED THE RESULTS OF A DIFFERENT MESH POSITIONING TECHNIQUE IN THE INTRAPERITONEAL ONLAY MESH MEDIATED ABDOMINAL WALL HERNIA REPAIR USING DUAL-MESH PROSTHESIS DEFINED ¿PERCUTANEOUS TECHNIQUE POSITIONING¿ INSTEAD OF THE CLASSIC POSITIONING TECHNIQUE. FOR ALL SURGICAL OPERATION, A THREE-DIMENSIONAL (3D) TEXTILE MONOFILAMENT POLYESTER (PET) MESH WITH BIOABSORBABLE COLLAGEN FILM WAS USED . FIXATION DEVICE WAS ALSO USED. THERE WERE 18 POSTOPERATIVE COMPLICATIONS WHICH INCLUDES WOUND INFECTION (5), HEMATOMA (5), SEROMA (7) AND RECURRENCE (1).

  Patient problems: Hematoma; No Code Available; Post Operative Wound Infection; Seroma

  MAUDE report 8497965 ↗
• MalfunctionMar 20, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE¿S CUTTING WAS BAD AND THE INSERTION WAS DIFFICULT. THEY COMPLETED THE CASE USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438788 ↗
• MalfunctionJan 3, 2019Component or Accessory Incompatibility; Human-Device Interface Problem; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING MINIMALLY INVASIVE ESOPHAGECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO LOAD AND ALSO DIFFICULT TO TOGGLE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8215324 ↗