Direct Drive Reposable GraspersRecalls & reported problems across all models

We found 3 models of Direct Drive Reposable Graspers by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Feb 29, 2016 and Jul 16, 2026 — classified as 8 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Direct Drive Reposable Graspers problems

Direct Drive Reposable Graspers models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Direct Drive Reposable Graspers C4120

  Laparoscopic Accessories, Gynecologic
  28 reports
• Direct Drive Reposable Graspers C4121

  Laparoscopic Accessories, Gynecologic
  15 reports
• Direct Drive Reposable Graspers C4119

  Laparoscopic Accessories, Gynecologic
  3 reports

Recent Direct Drive Reposable Graspers adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841455 ↗
• MalfunctionAug 26, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAVH EVENT DESCRIPTION: A PIECE OF THE GRASPER FELL OUTSIDE OF THE PATIENT. THE DEVICE WAS NOT ABLE TO GRASP. THE PIECE THAT FELL WAS ACCOUNTED FOR DURING THE PROCEDURE. THEY WERE TRYING TO GRASP UTERINE TISSUE. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2025: THE GRASPER WAS BEING USED TO GRASP THE UTERUS AND THE HINGE BECAME LOOSE. NOTHING BROKE OFF OR FELL INTO THE PATIENT; THE DEVICE JUST WOULD NOT GRASP. IT WAS REMOVED FROM THE PATIENT AND OFF THE FIELD WITH ALL PIECES INTACT. WHEN INSPECTING OFF THE FIELD, A PIECE FELL OUT FROM THE HINGE AREA. IT IS NOT VISIBLE IN THE PICTURE. IT IS MORE OF A PIECE OF METAL THAT FELL FROM THE INSIDE OF THE HINGE WHILE WE WERE INSPECTING IT. INTERVENTION: THE GRASPER WAS REMOVED FROM THE FIELD AND A NEW GRASPER WAS OPENED. PATIENT STATUS: NO ADVERSE EVENT OR INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898298 ↗
• MalfunctionAug 21, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: GRASPER WAS WORKING FINE WHEN TAKEN OUT OF PACKAGE. PRODUCT BROKE INSIDE PATIENT DURING OPERATION. HSS HAS RECEIVED A PRODUCT COMPLAINT FROM [HOSPITAL], SEE PRODUCT DETAIL BELOW: PRODUCT: DIRECT DRIVE REPOSABLE GRASPERS SUPPLIER PART NUMBER: N/A. BATCH: 1545993. SUPPLIER: APPLIED MEDICAL. COMPLAINT: ["DAMAGED/REQUIRES REPAIR OR REPLACEMENT". DESCRIPTION: GRASPER WAS WORKING FINE WHEN TAKEN OUT OF PACKAGING. PRODUCT BROKE INSIDE PATIENT DURING THE OPERATION. ACTION: PRODUCT WAS ASSESSED TO SEE IF ANY PARTS WERE POSSIBLY WITHIN THE PATIENT CAVITY. A NEW GRASPER WAS OPENED. IS PRODUCT AVAILABLE? YES. IS PACKAGING AVAILABLE? YES. CAN YOU PLEASE LIAISE DIRECTLY WITH THE COMPLAINANT TO ARRANGE PICK UP OF THE FAULTY ITEM/S. WE REQUEST THAT A WRITTEN CORRECTIVE ACTION PLAN IS PROVIDED, CLEARLY DEFINING A PLANNED SOLUTION AND A TIMEFRAME BY THE KPI DEADLINE OF 21 AUGUST 2025. NO CLINICAL IMPACT. ADDITIONAL INFO RECEIVED BY AMR REP VIA EMAIL ON AUGUST 18, 2025: 1. WHAT COMPONENT OF THE DEVICE BROKE? HINGE BROKE AND CAME LOOSE ON THE NECK OF GRASPER. 2. WHAT CIRCUMSTANCES THAT LED TO THE BREAK? THE CIRCUMSTANCES LEADING TO THE INCIDENT WAS THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868967 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP BSO. EVENT DESCRIPTION: PRIOR TO REPORTING, INTERNAL HOSPITAL DOCUMENT FILLED BY NURSE STATES: BLUE GRASPER TIP CAME OFF IN PATIENT DURING LAPAROSCOPIC SALPINGO-OOPHERECTOMY AND WAS LUCKILY SEEN AND FOUND IMMEDIATELY. FROM PCF ON 25JUN2025: GRASPER WAS BEING USED AS PER USUAL, AND THE OPERATING TEAM NOTICED THE BLUE "LATIS" PAD HAD FALLEN OFF THE GRASPER TIPS. ADDITIONAL INFORMATION WAS PROVIDED BY [NAME], AMA TERRITORY MANAGER VIA EMAIL ON 26-JUN-2025. THE LOT NUMBER OF THE COMPLAINT DEVICE WAS CONFIRMED AS 1538058. THE TERRITORY MANAGER BELIEVES IT WOULD HAVE BEEN ORDERED FROM [LOCATION]. INTERVENTION: DEVICE WAS REPLACED. PATIENT STATUS: UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384425 ↗
• MalfunctionFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HIATUS HERNIA REPAIR. EVENT DESCRIPTION: GRASPING TISSUE AND BOWEL DURING HIATUS HERNIA REPAIR, NO DIFFERENT TO ANY OTHER CASE. SURGEON REGULARLY USES 2X ATRAX GRASPERS IN EVERY HIATUS HERNIA REPAIR AND HAS NEVER HAD AN ISSUE. SURGEON MOVED THE CAMERA AND NOTICED THAT THE GRASPER WAS NOT GRASPING AS USUAL. WHEN HE MOVED THE CAMERA, HE NOTICED THE BLUE LATIS PAD IN THE CORNER OF THE SCREEN. UPON CHECKING THE GRASPER, THE PAD HAD FALLEN OFF AND INTO THE PATIENT'S ABDOMINAL CAVITY, OF WHICH HE RETRIEVED. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT AS LATIS PAD WAS FOUND AND RETRIEVED FROM PATIENT. SURGEON RETRIEVED LATIS PAD FROM PATIENT AND REPORTED VIA HOSPITAL REPORTING (RISK MAN) AND ADVISED ALL RELEVANT PERSONNEL AS PER HOSPITAL POLICY. INTERVENTION: LATIS PAD FROM GRASPER DETACHED FROM MAIN SHAFT AND WAS REMOVED BY SURGEON. PATIENT STATUS: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318216 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: COMPLAINT CREATED FROM MEDWATCH, MDR REPORT # MW5160650. THIS IS AN ANONYMOUS COMPLAINT FILED BY AN UNKNOWN REPORTER VIA MEDWATCH. THUS, NO FURTHER INFORMATION CAN BE OBTAINED. DURING SURGERY, THE GRASPER TIP WAS COMING OFF OF THE INSTRUMENT AND NOTICED. REMOVED FROM PATIENT AND DETERMINED ALL WAS STILL INTACT AND OUT OF THE PATIENT DURING REMOVAL AND AFTER REMOVAL. INSTRUMENT REMOVED FROM THE STERILE FIELD. INTERVENTION: REMOVED FALLEN GRASPER TIP FROM PATIENT. PATIENT STATUS: NI.

  Patient problems: Insufficient Information

  MAUDE report 20763695 ↗
• InjuryNov 15, 2024Sharp Edges; Sharp Edges

  NAME OF PROCEDURE BEING PERFORMED: ROBOTIC ASSISTED RIGHT HEMICOLECTOMY DESCRIPTION OF EVENT: [HOSPITAL] EVENT DATE: 18 SEP 2024 MODEL #: C4120 LOT #: 1519144 THE PROCEDURE WAS A ROBOTICS-ASSISTED RIGHT HEMICOLECTOMY. THE TIP OF THE GRASPER INJURED THE BOWEL WALL. THE DEVICE WAS USED FOR TWO MINUTES. THE PHYSICIAN DID NOT OPEN ANOTHER DEVICE. PATIENT STATUS: NI TYPE OF INTERVENTION: NI

  Patient problems: Insufficient Information

  MAUDE report 20700570 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  PROCEDURE PERFORMED: ROBOTIC LEFT PARTIAL NEPHRECTOMY. EVENT DESCRIPTION: THE DEVICE WAS USED AS INDICATED. GRASPER BLUE RUBBER TIP WAS BREAKING AWAY DETACHING FROM TIP OF GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, NO PATIENT INCIDENT WAS RECORDED. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INCIDENT RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323813 ↗
• MalfunctionAug 22, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC CYSTECTOMY EVENT DESCRIPTION: THE HANDLE WAS ATTEMPTING TO BE OPENED BUT THE JAWS WERE NOT MOVING. THE REPOSABLE GRASPER WAS BEING SCREWED ON NORMALLY AND THEN FAILED TO OPEN AND OPERATE. REP WAS PRESENT IN THE THEATRE. ANOTHER HANDLE WAS OPENED AND WAS SCREWED ONTO THE DIRECT DRIVE GRASPER AND AGAIN IT WOULDN'T WORK. CLINICAL IMPACT: NO, IT DID NOT GO NEAR THE PATIENT. (B)(6) 2024 RECEIVED CLARIFICATION THAT THE C4120 WAS TRIED ON A SECOND HANDLE TO DETERMINE WHAT WAS FAULTY AND IT TURNED OUT TO BE THE C4120. THERE IS ONLY ONE FAULTY DEVICE AND ONLY ONE DEVICE TO BE RETURNED. INTERVENTION: ANOTHER FORM OF GRASPER WAS USED. PATIENT STATUS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036558 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC HEMICOLECTOMY. EVENT DESCRIPTION: EMAIL WAS RECEIVED BY [NAME], AMA REGIONAL SALES MANAGER ON 30-MAY-2024 REGARDING AN EVENT AT THE HOSPITAL FROM [NAME], NURSE UNIT MANAGER, CLINICAL CONSUMABLES GROUP AT [HOSPITAL]. A PRODUCT COMPLAINT WAS INTERNALLY RAISED AT THE HOSPITAL REGARDING C4120 DIRECT DRIVE REPOSABLE GRASPER THAT BROKE OFF INSIDE A PATIENT. IT WAS STATED THAT THE PRODUCT WAS NOT X-RAY DETECTABLE. NUM WANTED A CONFIRMATION IF THE PRODUCT PART WAS X-RAY DETECTABLE. RSM SPOKE TO THE CUSTOMER AND CONFIRMED THAT COMPLAINT WAS SUBMITTED INTERNALLY IN THE HOSPITAL AND DUE TO STAFF SHORTAGES, THE METRO NORTH PROCUREMENT MAY TAKE SOME TIME TO PROCESS THE COMPLAINT AND SUBMIT TO US. PER RSM'S DISCUSSION WITH NUM, IT APPEARS THAT IT WAS THE POLYCARBONATE BIT THAT WAS DETACHED. THE NUM CONFIRMED THAT THE PATIENT IS SAFE, HOWEVER ADDED THAT THE FOREIGN BODY MIGHT STILL BE IN THE PATIENT. PROCEDURE WAS ROBOTIC HEMICOLECTOMY - THE PAD POPPED OFF AS THEY WERE USING IT TO PUT A [SPONGE] INTO ABDOMEN. PATIENT STATUS: PATIENT IS SAFE. INTERVENTION: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464247 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC COLON RESECTION. EVENT DESCRIPTION: THE PAD FROM THE TIP OF THE GRASPER DETACHED AND FELL INTO THE PATIENT'S CAVITY. IT WAS REMOVED SUCCESSFULLY, AND THE CASE WAS COMPLETED. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 6MAR2024 VIA EMAIL: I AM STILL WAITING FOR ADDITIONAL INFORMATION ABOUT HOW THE GRASPERS WERE BEING USED AT THE TIME OF THE INCIDENT. HOWEVER, I DO KNOW THAT THERE ARE NOT ANY PHOTOS TAKEN. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE PAD WAS REMOVED FROM THE PATIENT SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234610 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: SMALL BOWEL RESECTION EVENT DESCRIPTION: DR [NAME] WAS PERFORMING SMALL BOWEL RESECTION. THE PADDED ENDS CAME OFF WHEN USING THE INSERTS FOR THE LAPAROSCOPIC CASE. THE SURGEON HAD USED THIS DEVICE MANY TIMES PRIOR TO THIS EVENT. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. ANOTHER DEVICE WAS USED TO RESOLVE THE SITUATION. PATIENT STATUS: WHEN USING THE INSERTS THE PADDED ENDS CAME OFF AND CAUSED MINOR TRAUMA TO THE BOWEL. PATIENT IS UNHARMED AND DID NOT CHANGE TO PROCEDURE PERFORMED IN ANY WAY. INTERVENTION: USED ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233364 ↗
• MalfunctionMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  TYPE OF PROCEDURE: NI. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL]. PRODUCT: 45CM GRASPER. "ROBOTIC CASE. BLUE PADS (REPORTER ASSUMES BOTH BLUE PADS OF THE GRASPER) DETACHED AND FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PADS." PRODUCTS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT. INTERVENTION: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895138 ↗
• InjuryAug 21, 2023Material Frayed; Material Frayed

  PROCEDURE PERFORMED: LAPARASCOPIC RIGHT HEMICOLECTOMY. EVENT DESCRIPTION: THE SMALL BOWEL WAS BEING GRASPED DURING HEMICOLECTOMY WHEN THE EVENT OCCURRED. MESSAGE FROM CNS: [NAME] PERFORMING LAP RIGHT HEMI; "YESTERDAY WE HAD A FAULTY GRASPER (C4120 ¿ LOT:1465118). IT HAD A PIECE OF THE MESH MATERIAL STICKING OUT AND IT MADE A SMALL HOLE IN THE SMALL BOWEL. THE GRASPER WASN¿T CHECKED PRIOR TO USE BUT WAS NOTICED AS THE SURGEON GRABBED THE BOWEL WITH THE GRASPER AND A HOLE FORMED." THE SMALL BOWEL WAS PUNCTURED. IT WAS SUBSEQUENTLY REPAIRED. DEVICE REPLACED WITH ANOTHER C4120. ADDITIONAL INFORMATION RECEIVED FROM [NAME] VIA EMAIL ON (B)(6) 2023. SMALL BOWEL WAS REPAIRED BY SUTURING. BLEEDING AND SMALL BOWEL DAMAGE. INTERVENTION: SMALL BOWEL WAS REPAIRED BY SUTURING. DEVICE REPLACED WITH ANOTHER C4120. PATIENT STATUS: SMALL BOWEL WAS REPAIRED AND PATIENT IS STABLE.

  Patient problems: Bowel Perforation

  MAUDE report 17588611 ↗
• MalfunctionJul 20, 2023Material Frayed; Material Separation; Material Frayed; Material Separation

  PROCEDURE PERFORMED: LAPAROSCOPIC ROUX-EN-Y. TWO SIMILAR COMPLAINTS OCCURRED AT [USER FACILITY]: COMPLAINT 1 OF 2: (B)(4) - C4121 LOT #1472638 [MFR #2027111-2023-00528] COMPLAINT 2 OF 2: (B)(4) [MFR #2027111-2023-00529]. THE SURGEON USED TWO GRASPERS DURING "SOFT LAUNCH TESTING" AND ONE OF THE DEVICES EXPERIENCED FRAYING AT THE TIP OF THE LATIS PAD. THE SURGEON NOTICED THAT THE LATIS PAD WAS FRAYING TWO HOURS INTO THE THREE-HOUR PROCEDURE. THE OTHER DEVICE DID NOT EXPERIENCE FRAYING OR ANY OTHER ISSUES. THEY WERE ABLE TO FINISH THE PROCEDURE NORMALLY. THERE WAS NO IMPACT TO THE CASE. NO PATIENT INJURY. THE SURGEON NOTED THAT THEY HAVE SEEN THIS ISSUE IN THE PAST BUT THE DEVICE ALWAYS PERFORMED AS NEEDED. BOTH DEVICES USED DURING THE PROCEDURE ARE RETURNING FOR COMPLAINT #(B)(4). [] ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 23JUN2023 FROM [NAME], CLINICAL DEVELOPMENT ANALYST II, APPLIED MEDICAL: NO, THE USER DID NOT EXPERIENCE ANY TISSUE STICKING OR TEARING WHEN USING THE FRAYED DEVICE. "THE GRASPERS WERE BEING USED TO HANDLE TISSUE DURING A BARIATRIC ROUX-EN-Y PROCEDURE. THESE TISSUES/ORGANS INTERACTED WITH INCLUDE THE STOMACH, SMALL INTESTINE, FAT TISSUE (OMENTUM AND VISCER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367904 ↗

Other Applied Medical Resources Corporation products

• Inzii Retrieval System3 models · 796 reports
• Kii Fios First Entry18 models · 587 reports
• Kii Optical Access System18 models · 309 reports
• Kii Balloon Blunt Tip System3 models · 263 reports
• VOYANT 5mm Fusion Device4 models · 257 reports
• Epix Laparoscopic Scissors2 models · 245 reports
• VOYANT Maryland Fusion Device5 models · 132 reports
• Kii Sleeve7 models · 130 reports