Endo Grasp 174233Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884523000818), received between Apr 29, 2016 and Nov 14, 2024 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VETERINARY PROCEDURE, THE PLASTIC COATING ON THE RETICULATION PORTION OF THE INSTRUMENT WAS TORN. THE INNER PIECE WAS SCRAPING ALONG THE OUTER SHAFT OF THE INSTRUMENT, THUS PEELING WAYS THE OUTER PLASTIC COATING.

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

  MAUDE report 20691614 ↗
• MalfunctionOct 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER PRE-OPERATIVELY FOR VET PROCEDURE, THE USER OPENED UP A BRAND-NEW GRASPER, AND THE PLASTIC COATING WAS TORN, AS SUCH THE SURGEON WAS UNABLE TO USE IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20380153 ↗
• MalfunctionDec 15, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING SINGLE HOLE LAPAROSCOPIC CHOLECYSTECTOMY, WHEN INSERTED FROM THE TROCAR FOR USE, A TEAR WAS FOUND IN THE COVER OF ARTICULATION PART. THE DEVICE WAS DISCONTINUED FROM USE IN ORDER TO PREVENT COMPONENT FROM FALLING INTO THE BODY CAVITY AND ANOTHER PRODUCT WAS OPENED AND 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 15991671 ↗
• MalfunctionOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DIAL WAS TURNED TO STORE THE FORCEPS. THE SHAFT WAS THEN EXTENDED BY TURNING THE DIAL IN THE ABDOMINAL CAVITY TO ATTEMPT TO GRASP THE GALL BLADDER, WHEN A VINYL-LIKE SUBSTANCE CAME OUT FROM THE INSIDE OF THE SHAFT. THE VINYL-LIKE SUBSTANCE DID NOT DROP IN THE ABDOMINAL CAVITY. THE FORCEPS WERE IMMEDIATELY TAKEN OUT LAPAROSCOPICALLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680746 ↗
• MalfunctionSep 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, AT THE BEGINNING OF THE SURGERY, THE RELEVANT FORCEPS FROM THE PORT WERE INSERTED INTO THE PATIENT'S ABDOMINAL CAVITY, BUT IT WAS BEFORE GRASPING THE TISSUE, THE DIAL WAS TURNED AND THE ARTICULATION ANGLE WAS SET TO 0°. THE SURGEON INSERTED THE FORCEPS FROM THE PORT AND TURNED THE DIAL TO SET THE ARTICULATION ANGLE TO 80°, THEN THE SURGEON FOUND SOMETHING LIKE VINYL COMING OUT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457356 ↗
• MalfunctionSep 13, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A SINGLE PORT LAPAROSCOPIC CHOLECYSTECTOMY, BEFORE THE DEVICE WAS USED TO THE PATIENT, A SCRATCH W AS OBSERVED ON THE PLASTIC COVERING THE ARTICULATION PART IN FRONT OF THE GRASPING PART OF THE TIP WHEN IT WAS OPENED. WHEN THE TIP WAS RETRACTED INTO THE SHAFT IN ORDER TO USE, IT WAS TORN FROM THE SCRATCH, SO USE WAS DISCONTINUED. A NEW PRODUCT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411476 ↗
• MalfunctionJul 20, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, AFTER REPEATEDLY TURNING THE HANDLE OF THE GRASPERS AND THE DISSECT OF THE RELEVANT PRODUCT, ARTICULATING THE TIP, TURNING THE HANDLE IN THE OPPOSITE DIRECTION, AND PLACING IT TO A STRAIGHT POSITION, THE TRANSPARENT FILM FROM THE ARTICULATION PART CAME OFF. A NEW PRODUCT WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068056 ↗
• MalfunctionJul 13, 2022Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC CHOLECYSTECTOMY CASE, WHILE PREPARING AND WHEN THE NURSE PERFORMED THE OPERATION CHECK OF THE CENTER ROD DIAL, THERE WAS A RESISTANCE IN THE REPORTED PRODUCT. WHEN CHECKING THE MOVABLE PART, THE TRANSPARENT PART BECAME IN A STATE THAT A SINGLE PIECE OF SKIN SEEMED TO PEEL OFF. THE DEVICE DID NOT PROPERLY GRASP. THE REPORTED PRODUCT WAS NOT USED, AND A NEW PRODUCT OF THE SAME LOT WAS USED TO RESOLVE THE ISSUE. AFTER THE CASE, INVENTORY WAS CHECKED AND ANOTHER DEVICE FROM THE SAME LOT HAD THE SAME TRANSPARENT LEATHER-LIKE PIECE PEELED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001658 ↗
• MalfunctionApr 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE COATING OF THE DEVICE WAS WORN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212351 ↗
• MalfunctionDec 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, A COMPONENT FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090762 ↗
• MalfunctionOct 21, 2021Break; Break

  ACCORDING TO THE REPORTER, AFTER REPEATED ARTICULATION, THE DEVICE GOT DAMAGED WITH A RUB-LIKE SCRATCH ON THE SEMI-TRANSPARENT PART OF THE ARTICULATION. THIS HAPPENED DURING LAPAROSCOPIC TOTAL CYSTECTOMY. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675836 ↗
• InjuryApr 13, 2021Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON A SINGLE INCISION LAPAROSCOPIC CHOLECYSTECTOMY, IN THE BEGINNING OF THE PROCEDURE, THE JAW OF THE DEVICE WOULD NOT OPEN. THE DEVICE GOT LOCKED ONTO THE TISSUE. THE SURGEON HAD TO USE ENERGY DEVICES TO RESECT THE TISSUE FROM THE GRASPER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11657322 ↗
• MalfunctionFeb 25, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING DEVICE FOLLOW UP, THE TRANSPARENT PLASTIC MEMBRANE THAT COMES OUT OF THE SHAFT WHEN THE ROTICULATOR JAW IS ACTIVATED, TORN UNEXPECTEDLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378384 ↗
• MalfunctionSep 28, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING SINGLE-INCISION LAPAROSCOPIC CHOLECYSTECTOMY, WHEN GRIPPING THE SALVAGE BAG CONTAINING THE DETACHED GALLBLADDER, THE FORCEPS WAS STRAIGHTENED AT THE ROTATING MECHANISM AND THE DEVICE BROKE RIGHT BEHIND THE ANVILS. THE PLASTIC SHEATHING OF THE INNER WIRE ON THE PLASTIC OUTER SHEATH HAD BEEN CUT OPEN. THE PLASTIC PIECE REMAINED ON THE DEVICE. TOOK ANOTHER GRASPING FORCEPS WITH THE SAME LOT NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10592136 ↗
• MalfunctionAug 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HIATAL HERNIA REPAIR, WHEN THE SURGEON WAS PREPARING TO MANEUVER THE DEVICE BEHIND THE ESOPHAGUS, THE ROTATION AND ARTICULATION KNOBS WERE USED THEN A PART OF THE PLASTIC HOUSING CAME OFF INSIDE THE PATIENT. THE PLASTIC WAS RETRIEVED WITH GRASPERS WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395151 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF THE STUDY, PERFORMED BETWEEN MAY 2011 AND SEPTEMBER 2014, 10 ULCERATIVE COLITIS (UC) PATIENTS UNDERWENT SINGLE-INCISION PLUS ONE PORT LAPAROSCOPIC SURGERY (SILS + 1). ALL PROCEDURES WERE PERFORMED USING A 5-MM STANDARD DEFINITION FLEXIBLE SCOPE, ULTRASONIC-ACTIVATED SCISSORS, ACTIVATING LAPAROSCOPIC COAGULATING SHEARS, AND STRAIGHT AND CURVED GRASPERS. THE END OF THE ILEUM WAS CUT WITH THE REPORTED STAPLER, AND THE ASCENDING COLON WAS MOBILIZED TO THE HEPATIC FLEXURE WITH A RETROPERITONEAL APPROACH. TRANSANAL MUCOSECTOMY WAS PERFORMED ABOVE THE DENTATE LINE, AND THE CIRCUMFERENTIAL MUSCULAR LAYER OF THE RECTUM WAS TRANSECTED WITH A STAPLING DEVICE OR TWO FIRINGS OF A LINEAR CUTTING ROTICULATING STAPLER. POST-OPERATIVELY, ONE PATIENT HAD METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) ENTERITIS WHICH RESOLVED WITH CONSERVATIVE MANAGEMENT. DOES REDUCED-PORT LAPAROSCOPIC SURGERY FOR MEDICALLY UNCONTROLLED ULCERATIVE COLITIS DO MORE HARM THAN GOOD? 2016 SHIGENORI HOMMA, FUTOSHI KAWAMATA, SUSUMU SHIBASAKI, HIDEKI KAWAMURA, NORIHIKO TAKAHASHI & AKINOBU TAKETOMI.

  Patient problems: No Code Available

  MAUDE report 10269904 ↗
• MalfunctionMar 13, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIATAL HERNIA REPAIR, THE DEVICE DID NOT GRASP PROPERLY AND THE GRASPER FELL INTO THE CAVITY OF THE PATIENT. SURGEON REMOVED IT WITH ADDITIONAL GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831800 ↗
• MalfunctionMar 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER DISSECTING ON LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, THE GRASPER WAS USED TO GO AROUND THE ESOPHAGUS WHEN THE PRODUCT SIMPLY FELL APART. THE PORTION THAT BROKE WAS RETRIEVED WITH A GRASPER AND OPENED A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812744 ↗
• MalfunctionDec 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE HAD A CRACK AT THE BLACK PART OF THE TIP. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9502131 ↗
• MalfunctionJul 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE ON A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON WAS CHECKING EXTENSION, ROTATION AND ARTICULATION OF THE DEVICE BEFORE PATIENT ENTERING THE OPERATING ROOM, WHEN IT WAS EXTENDED IT APPEARED TO SHEAR OPAQUE PLASTIC ON THE SHAFT OF THE INSTRUMENT. THE NEW INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8814468 ↗
• MalfunctionDec 27, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING A CASE OF EXCISION OF MEDIASTINAL LESION AND THORACOSCOPY, BOTH DEVICE HAD THEIR COATING PEELED-OFF AFTER JUST ONE USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8199927 ↗
• MalfunctionSep 5, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE DEVICE WAS OPENED AND THE ACTIVATION WAS CHECKED, THE JAWS COULD NOT OPEN. A NEW PRODUCT WAS OPENED AND THE PROCEDURE WAS PERFORMED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847554 ↗
• MalfunctionJun 11, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE DEVICE WAS PULLED OUT, THE JAW WAS CRACKED AND BROKEN. THE BALLOON LEAKED GAS OR AIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7586938 ↗
• MalfunctionMar 8, 2018Melted; Melted

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AFTER 10 OR 15 MINUTES WHILE USING THE DEVICE UPON GRASPING LIFTED CHOLECYST, THE DEVICE GOT DEFORMED. THE SURGEON REPORTED THAT IT MELT, NO EXCESSIVE LOAD WAS ADDED AND ELECTRICAL CAUTERY DID NOT HIT THE DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES AND THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7324959 ↗
• MalfunctionFeb 20, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, OCCURRED PRIOR TO A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. UPON OPENING THE PACKAGE, TRIED TO OPEN AND C LOSE THE DEVICE. BUT IT WOULD NOT OPEN COMPLETELY. THE DEVICE WAS NOT USED ON A PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7283907 ↗