Endo Grasp 173030Recalls & reported problems
Covidien LP · Grasper · Class 2
All models of Endo Grasp (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Endo Grasp is a surgical grasper (forceps) used to hold and remove tissue. Most of the 34 reports describe the instrument breaking or coming apart during surgery or even while still in the package, sometimes leaving a small screw or fragment inside the patient; a few mention it not gripping properly or sticking. No deaths and no injuries were reported. There are no recalls for this device, and reports in the past 12 months (4) stayed near the level of the prior year (2).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884523000757), received between Dec 21, 2016 and Jul 28, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (25 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break25
- Detachment of Device or Device Component13
- Failure to Align2
- Physical Resistance/Sticking2
- Detachment Of Device Component1
- Device Fell1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Known Impact Or Consequence To Patient10
- Insufficient Information3
- No Consequences Or Impact To Patient3
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061973 ↗MalfunctionJun 23, 2026Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROSCOPIC SURGERY, THE CLAMP BROKE DURING REMOVAL. IT WAS NOTICED THAT A SCREW WAS MISSING ON THE CLAMP. THE SURGEON FOUND THE TINY SCREW IN THE PATIENT¿S BELLY AND WAS ABLE TO RETRIEVED IT.
Patient problems: Insufficient Information
MAUDE report 25596521 ↗MalfunctionFeb 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO USE, TWO DEVICES DISASSEMBLED WHEN THE HANDLE WAS SQUEEZED IT CAME APART AND DID NOT GRASP PROPERLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24240103 ↗MalfunctionDec 26, 2025Break; Break
IT WAS REPORTED THAT THE GRASPER BROKE.
Patient problems: Insufficient Information
MAUDE report 23897959 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT PREOPERATIVELY, THE END OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22609067 ↗MalfunctionMar 3, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE GRASPER DEVICE EXPERIENCED SEVERAL ISSUES AT THE START OF THE PROCEDURE. PART OF THE FRESHLY OPENED, THE DEVICE PHYSICALLY BROKE, THE DEVICE DID NOT GRASP PROPERLY. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW GRASPER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21504787 ↗MalfunctionSep 3, 2024Break; Break
ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE PACKAGING WAS OPENED, IT WAS FOUND OUT THAT THE NECK OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20126014 ↗MalfunctionJul 10, 2024Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE DEVICE WAS OPENED, IT WAS FOUND TO BE BROKEN. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19713288 ↗MalfunctionFeb 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SCREW OF THE THREE DEVICES THAT HELD THE PRONOUNCED TEETH CAME LOOSE, PREVENTING FURTHER USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697468 ↗MalfunctionFeb 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SCREW OF THE THREE DEVICES THAT HELD THE PRONOUNCED TEETH CAME LOOSE, PREVENTING FURTHER USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697305 ↗MalfunctionJan 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SCREW THAT HELD THE PRONOUNCED TEETH OF THE DEVICE CAME LOOSE, PREVENTING FURTHER USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18541708 ↗MalfunctionSep 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A RIGHT COLON NEOPLASM, WHEN USING THE GASPER INSIDE THE ABDOMINAL CAVITY, THE USER DETECTED AN ABNORMAL ANGULATION AT THE TIP OF THE FORCEPS, THE INSTRUMENT WAS INSPECTED THROUGH OPTICS SEEING THAT A SCREW/RIVET OF THE FASTENING HAS BECOME LOOSE AND FELL INTO THE PATIENT CAVITY AND THE SCREW WAS RETRIEVED WITH GRASPING LAPAROSCOPE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17775406 ↗MalfunctionApr 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE SCREW OF THE PIN ON THE MOUTH OF THE DEVICE FELL INTO THE PATIENT BUT WAS LATER REMOVED. ANOTHER GRASPER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16762009 ↗MalfunctionOct 13, 2022Break; Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN USER STARTED WITH THE DEVICE, THE ANTERIOR BLADE BROKE SO IT WAS NOT USED ON THE PATIENT. ANOTHER DEVICE WAS USED TO CONTINUE THE CASE.
Patient problems: Insufficient Information
MAUDE report 15601031 ↗MalfunctionSep 19, 2022Break; Mechanical Problem; Detachment of Device or Device Component; Break; Mechanical Problem; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, WHILE AT THE UTERUS, THE DEVICE DID NOT GRASP PROPERLY AND PART OF THE JAW FELL INTO PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT. ANOTHER GRASPER WAS USED TO RETRIEVE THE COMPONENT AND CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15451812 ↗MalfunctionJul 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN OPENING THE PACKAGE, THE SCREW FELL OUT OF THE CLAMP BASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14961168 ↗MalfunctionMay 19, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIGH ANTERIOR RESECTION OF THE RECTUM X PCL (POSTERIOR CRUCIATE LIGAMENT) SURGERY, WHILE INSIDE THE PATIENT, THE PRE CLAMP BLACK PLASTIC BROKE. A NEW GRASPER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14436342 ↗MalfunctionSep 30, 2021Break; Break
ACCORDING TO THE REPORTER, THE SCREWS THAT FIXING THE TWO JAWS OF THE GRASPERS GOT UNSCREWED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557524 ↗MalfunctionMay 14, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTALLY EXTRAPERITONEAL PREPERITONEAL HERNIA REPAIR, THE SURGEON WAS SIMPLY GRASPING TISSUE WHEN THE JAW BROKE OFF AND SCREW FELL OFF INTO THE PATIENT'S CAVITY. THE HANDLES DID NOT BIND. THE USER RETRIEVED THE COMPONENTS IMMEDIATELY AND CONTINUED THE CASE USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11827320 ↗MalfunctionApr 28, 2021Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE DEVICE TOOK OUT FROM THE PACKAGE IT BROKE INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11739999 ↗MalfunctionSep 12, 2019Break; Break
ACCORDING TO THE REPORTER, THE DEVICE¿S JAW NOT USED BECAUSE IT IS PIERCED. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9014485 ↗MalfunctionMay 31, 2019Break; Break
ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WAS USE FOR GRASPING AND THE TIP OF THE DEVICE WAS BROKEN IN THE MIDDLE OF SURGERY. THE NEW PRODUCT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8657677 ↗MalfunctionFeb 11, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, WHILE GRASPING THE UTERINE MYOMA, THE DEVICE SUDDENLY BROKE FROM THE TOP OF THE HEAD. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8327351 ↗MalfunctionOct 16, 2018Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
ACCORDING TO THE REPORTER, WHEN GRASPING LOBE OF A LUNG DURING A LAPAROSCOPIC LOBECTOMY, THE GRASPER FELL APART. THE HANDLES WERE BINDING WHILE CLAMPED ON TISSUE. THE SURGEON HAD BEEN GRASPING TISSUE BEFORE THIS WITH NO DIFFICULTY. THEY PULLED ANOTHER GRASPER AND CONTINUED WITH THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7969354 ↗MalfunctionSep 11, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MYOMECTOMY, WHEN THE DOCTOR USED THE GRASP TO CLAMP THE TISSUE, THE SHEET OF THE JAW WAS BROKEN. THEY CHANGE THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7865625 ↗
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-1213-2019 · Mar 13, 2019 · TerminatedProcedure 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 AP
- Z-1212-2019 · Mar 13, 2019 · TerminatedCovidien 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, urolog
- Z-1211-2019 · Mar 13, 2019 · TerminatedCovidien 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 approximately 3
Other Forceps, obstetrical devices
- Endo Clinch II 174317Covidien LP · Forceps, obstetrical147 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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