Endo Clinch II 174317Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 10884523000832), received between May 4, 2017 and Jun 24, 2026 — classified as 16 injuries, 131 malfunctions.

The most frequently reported specific device problem is “Break” (73 reports).

3 other recalls cover devices cleared under the same FDA submission (K903205); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Break; Mechanical Problem; Difficult to Remove

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY FOR APPENDICITIS, A 5 MM FORCEPS DID NOT GRASP PROPERLY, AND A SCREW ON THE FORCEPS CAME LOOSE, PREVENTING THE INSTRUMENT FROM BEING REMOVED THROUGH THE TROCAR. IT WAS NOTED THAT THE SCREW DID NOT FELL INTO THE CAVITY. THE FORCEPS AND TROCAR WERE REMOVED SIMULTANEOUSLY. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES WHILE ATTEMPTS WERE MADE TO REMOVE THE INSTRUMENT, AND THE INCISION WAS EXTENDED BY LESS THAN AN INCH. A NEW TROCAR WAS PLACED, AND A NEW GRASPER WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: Laceration(s)

  MAUDE report 25604570 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE FIRST DEVICE'S JAWS FELL OFF THE ENVELOP AND NOT IN THEIR PROPER POSITION AND THE SECOND DEVICE, WHEN SQUEEZING THE CLINCH, THE WHITE PART OF THE DEVICE BROKE. THE PRODUCTS WERE REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944518 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS DETECTED TO BE BROKEN BY A SURGICAL INSTRUMENT TECHNICIAN WHEN PASSING THE INSTRUMENT TO THE TABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777066 ↗
• InjuryMar 5, 2026Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, WHILE MOBILIZING STRUCTURES WITHIN THE ABDOMINAL CAVITY, THE DEVICE DID NOT GRASP PROPERLY. THE BLADE RETAINING SCREW FELL INTO THE ABDOMINAL CAVITY AND HAS NOT BEEN RECOVERED. SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM, WITH ADDITIONAL TIME SPENT ATTEMPTING TO LOCATE THE MISSING COMPONENT, WHICH WAS NOT FOUND IN THE ABDOMINAL CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24526839 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, THE GRASPER OR SHEARS DEVICE DID NOT GRASP PROPERLY, THE HANDLE DID NOT BIND AND THE CLAMP DETACHED WHEN THE HANDLE WAS SQUEEZED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250679 ↗
• MalfunctionFeb 3, 2026Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, DURING PREPARATION, THE DEVICE HANDLE CASING HAS OPENED WHICH CAUSED THE JAWS TO NOT CLOSE PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243551 ↗
• MalfunctionNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, THE DEVICE LOST ITS PLASTIC COATING WHICH WAS NOTED TO BE TORN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494903 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT, PREOPERATIVELY, THE JAWS OF THE DEVICE WERE UNSTABLE OR LOOSE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286149 ↗
• InjuryApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE INVOLVING MEMBRANE CLAMPING, THE TIP OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. ALL DISLODGED COMPONENTS WERE SUCCESSFULLY RETRIEVED THROUGH VISUAL INSPECTION AND CONFIRMED WITH AN X-RAY. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21900238 ↗
• MalfunctionMar 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE HANDLE DID NOT BIND. A NEW CLAMP WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643036 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE HANDLE WAS SQUEEZED TO INSERT IT INTO THE ABDOMINAL CAVITY FROM THE TROCAR AFTER OPENING, THE DEVICE WAS DISASSEMBLED LIKE A COLLECTED PRODUCT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PARTS FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560914 ↗
• MalfunctionNov 27, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE OPENING AND CLOSING THE DEVICE JAWS INSIDE THE ABDOMINAL CAVITY, THE BOLT CAME OFF AND THE JAW WAS DETACHED FROM THE SHAFT. THE BOLT THEN FELL INTO THE PATIENT'S CAVITY. ANOTHER LAPAROSCOPIC HAND INSTRUMENT WAS USED TO RETRIEVE THE BOLT. TO COMPLETE THE CASE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20798103 ↗
• MalfunctionNov 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE USING THE ENDO CLINCH II, ONE OF THE JAWS OF THE CLINCH FELL INTO THE PATIENT'S CAVITY. THE DEVICE WAS BEING APPLIED TO THE COLON AT THE TIME OF THE ISSUE. THE ISSUE WAS RESOLVED BY RETRIEVING THE FALLEN PIECE AND CONTINUING THE PROCEDURE WITH ANOTHER ENDO CLINCH. THERE WAS NO NEED FOR AN X-RAY TO LOCATE THE COMPONENT, AND NO INJURY, TISSUE DAMAGE, OR SIGNIFICANT BLOOD LOSS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728878 ↗
• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHILE USING IN THE ABDOMEN, THE PLASTIC BLACK COATING ON THE SHAFT PEELED AWAY AND FELL INTO THE PATIENT, BUT IT WAS RETRIEVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632093 ↗
• InjuryJul 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE TIP WAS DAMAGED IN THE INTRAPERITONEAL CAVITY. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE COMPONENT AND THE DOCTOR RETRIEVED IT FROM THE ABDOMINAL CAVITY USING FORCEPS.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19793630 ↗
• MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON SURGERY, ON MANAGING THE DESCENDANT COLON, THE SURGEON FORCED THE DEVICE BECAUSE THE TISSUE WAS VERY HARD. THE DEVICE GOT TWISTED AND THE SCREW BETWEEN THE JAWS OF THE GRASPER FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON MANAGED TO RECOVER AND TAKE OUT THE SCREW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19198241 ↗
• MalfunctionApr 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, ON THE CLAMPING OF THE GALL BLADDER FOR DISSECTION, THE TIP OF THE INSTRUMENT FULLY SEPARATED FROM THE SHAFT. THE DEVICE WAS RECOVERED WITH ANOTHER GRIPPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101567 ↗
• MalfunctionMar 25, 2024Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN UNBOXING THE DEVICE, IT WAS REALIZED THAT IT WAS DAMAGED. THE DEVICE HAS SCRATCH MARKS ON IT, ALONG ITS LENGTH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969547 ↗
• MalfunctionMar 8, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, WHEN THE RELOAD OF THE OPEN STAPLER WAS BEING MOUNTED, THE RELOAD WAS NOT ANCHORED CORRECTLY AND THE STAPLER COULD NOT BE CLOSED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. IT WAS ALSO REPORTED THAT WHEN THEY PERFORMING A COLORECTAL ANASTOMOSIS THE CLAMP WAS DAMAGED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE REPORTED CLAMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871639 ↗
• MalfunctionJan 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ANATOMICAL AND FUNCTIONAL RECONSTRUCTION OF THE ABDOMINAL WALL PROCEDURE, AT THE TIME OF DISSECTION, THE SCREW FELL INTO THE ABDOMINAL CAVITY, AND THE CLAMP AND JAWS WERE DISLODGED. HOWEVER, THE SCREW COULD BE RECOVERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591518 ↗
• MalfunctionDec 29, 2023Break; Mechanical Problem; Break; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL NEPHRECTOMY, THE DEVICE DISASSEMBLES WHEN GRASPING THE TISSUES AND IT STOPPED WORKING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419417 ↗
• MalfunctionDec 14, 2023Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN AT THE TRACTION VESICLES, THE DEVICE HAD LOW STRENGTH AND LOOSENED. IT DID NOT PERFORM ITS FUNCTION OF TRACTION AND GRASPING OF THE PERITONEUM IN THE GALLBLADDER. IT DID NOT WORK PROPERTY AND WHATEVER IT WAS TRYING TO GRASP CAME LOOSE. A NEW DEVICE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332455 ↗
• MalfunctionDec 1, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY BILATERAL INGUINAL HERNIORRHAPHY, WHEN THE CLAMP WAS PASSED AND THE SURGEON MANIPULATED THE TISSUE AS NORMALLY DO, THE CLAMP BROKE INTO MULTIPLE PARTS. NO COMPONENTS FELL INTO THE CAVITY OF THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247775 ↗
• InjuryNov 27, 2023Break; Mechanical Problem; Detachment of Device or Device Component; Break; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE JAWS BROKE AND THE BOLT CAME LOOSE INTO THE CAVITY OF THE PATIENT, IT WAS NOTED THAT THE SCREW WAS NOT FOUND. THE USER REPORTED THAT THE DEVICE DID NOT GRASP PROPERLY. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18213020 ↗
• MalfunctionNov 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE GRASPER JAW BROKE AND FELL INTO THE PATIENT CAVITY. THE JAW WAS RETRIEVED, AND THE DEVICE WAS CHANGED. IT WAS ALSO STATED THAT THE TROCAR USED WAS LEAKING AIR OR GAS FROM THE SEAL. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155473 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K903205. One submission often covers many models, so check the product and lot details in each record.

• Z-1212-2019 · Mar 13, 2019 · Terminated
  Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, uro
• Z-1211-2019 · Mar 13, 2019 · Terminated
  Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximatel
• Z-1213-2019 · Mar 13, 2019 · Terminated
  Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT