Epix Laparoscopic GrasperRecalls & reported problems across all models

We found 2 models of Epix Laparoscopic Grasper by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Feb 24, 2016 and Sep 23, 2026 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 Epix Laparoscopic Grasper problems

Epix Laparoscopic Grasper models

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

• Epix Laparoscopic Grasper C4130

  Laparoscopic Accessories, Gynecologic
  35 reports
• Epix Laparoscopic Grasper C4140

  Laparoscopic Accessories, Gynecologic
  5 reports

Recent Epix Laparoscopic Grasper adverse event reports

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

• MalfunctionSep 23, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876294 ↗
• MalfunctionMay 1, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAP CHOL EVENT DESCRIPTION: THE DEVICE WAS BEING USED DURING PULLING TISSUE. PULLING AWAY TISSUE WITH FORCE THE JAW BROKE OFF. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09APR26: THE JAWS FULLY DETACHED AND ALL THE MATERIALS WERE RETRIEVED FROM THE PATIENT. NO INFORMATION ON THE FOLLOWING, WHAT WAS THE SURGEON GRASPING WHEN THE BREAKAGE OCCURRED. INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062232 ↗
• MalfunctionMar 10, 2026Sharp Edges

  PROCEDURE PERFORMED: NISSEN FUNDOPLICATION. EVENT DESCRIPTION: THE DEVICE WAS USED FOR GRASPING THE STOMACH DURING THE STOMACH MOBILIZATION. AS SOON AS THE DEVICE GRASPED THE STOMACH THERE WAS INJURY AND BLEEDING OF THE STOMACH WHICH WAS CAUSED, ACCORDING TO THE SURGEON'S OPINION, BY THE TRAUMATIC LATIS PADS. THERE WAS NOT ANY CLINICAL IMPACT TO THE PATIENT OTHER THAN BLEEDING, WHICH WAS IMMEDIATELY CONTROLLED BY THE SURGEON, BY STITCHING THE TRAUMA. A DEVICE OF ANOTHER MANUFACTURER WAS USED TO CONTINUE THE SURGICAL OPERATION. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20FEB26: THE CORRECT LOT NR. IS 1563295. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27FEB26: THE BLEEDING OF THE STOMACH LINING OCCURRED AS A RESULT OF USING THE FORCEPS ON THE STOMACH. THEY STITCHED UP THE STOMACH AND CONTINUED THE SURGERY. THE PATIENT¿S CONDITION IS FINE. NO OTHER PRODUCT WAS INVOLVED. THE INCIDENT OCCURRED IMMEDIATELY AFTER THE FORCEPS GRASPED THE STOMACH WALL. RIPS, TEARS OR FRAYS WEREN'T OBSERVED ON THE PAD BEFORE GRASPING. INTERVENTION: A DEVICE OF ANOTHER MANUFACTURER WAS USED TO CONTINUE THE SURGICAL OPERATION PATIENT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24565310 ↗
• MalfunctionAug 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PROCEDURE PERFORMED: COLOSTOMY REVERSAL. EVENT DESCRIPTION: THE EPIX GRASPER BROKE BEFORE THE CASE STARTED. THE MODEL WAS C4140. ADDITIONAL INFORMATION PROVIDED BY ACCOUNT MANAGER VIA EMAIL ON 24JUL2025: DEVICE TIP BROKE OFF INSIDE THE PROTECTIVE CASING DURING THE SET UP FOR THE CASE. IT WAS REPLACED WITH ANOTHER UNIT PRIOR TO THE CASE BEGINNING. THE SURGEON WAS NEVER AWARE OF THE ISSUE. LOT # 1546467. TECH WHO HANDLED THE DEVICE AND EXPERIENCED THE ISSUE WAS [NAME]. SURGEON WAS DR [NAME]. SURGERY WAS A COLOSTOMY REVERSAL. INTERVENTION: REPLACED WITH ANOTHER DEVICE. PATIENT STATUS: NA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709472 ↗
• MalfunctionJun 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: GASTRIC SLEEVE DETAILED DESCRIPTION OF EVENT: NURSE WENT TO OPEN AND NOTICED A HAIR INSIDE THE PACKAGING NIL CLINICAL IMPACT ADDITIONAL INFORMATION RECEIVED FROM APPLIED'S SENIOR TERRITORY MANAGER VIA EMAIL ON MAY 27, 2025: HOSPITAL CANNOT GIVE US A DATE. ONLY THAT IT WAS FOUND YESTERDAY. TYPE OF INTERVENTION: THEY GRABBED A NEW DEVICE AND OPENED IT TO COMPLETE THE CASE PATIENT STATUS: NO PATIENT INVOLVEMENT (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197881 ↗
• MalfunctionFeb 7, 2025Material Frayed; Sharp Edges; Material Frayed; Sharp Edges

  PROCEDURE PERFORMED: APPENDIX. EVENT DESCRIPTION: THE GRASPER REPEATEDLY GET CAUGHT ON THE BOWEL DURING SURGERY AND THUS CAUSE INJURIES. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA EMAIL ON 04FEB25: THE GRASPER GOT CAUGHT AT THE PROXIMAL END OF THE PADDING. NO INJURY. THE INTESTINE HAS BECOME STUCK AT THE PROXIMAL END OF THE PADDING (SEVERAL TIMES DURING SURGERY). INTERVENTION: INTESTINE SHAKEN OFF THE GRASPING. PATIENT STATUS: NO INJURY. PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337184 ↗
• MalfunctionDec 13, 2024Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: EVENT DESCRIPTION: TWO OF TWO COMPLAINTS FOR THIS REPORT: (B)(4) (COMPLAINT #1) (B)(4) (COMPLAINT #2) GRASPER WAS BEING USED TO REMOVE THE GALL BLADDER. SURGEON HEARD A CRACK WHEN CLOSING THE HANDLE AND THE GRASPER LOCKED UP. SURGEON GRABBED A SECOND GRASPER AND THE JAWS WOULD NOT CLOSE ALL THE WAY. THE THIRD GRASPER WORKED AND WAS USED TO COMPLETE THE CASE. ACCOUNT MANAGER WAS ONSITE AND CONFIRMED THE FINDINGS OF THE SURGEON FOR THE FIRST TWO GRASPERS. NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION PROVIDED BY [ACCOUNT MANAGER] ON 28FEB2024 VIA EMAIL: I SPOKE WITH THE CUSTOMER AGAIN LAST NIGHT AND SHE INFORMED ME THAT THE INCIDENT OCCURRED ON MONDAY 2/26, NOT YESTERDAY. THANK YOU FOR YOU ASSISTANCE. PLEASE LET ME KNOW IF THERE IS ANYTHING ELSE I CAN ASSIST WITH. ADDITIONAL INFORMATION PROVIDED BY [ACCOUNT MANAGER] ON 28FEB2024 VIA EMAIL: THE JAWS DID NOT DETACH OR BREAK OFF. NO MATERIALS WERE LOST IN THE PATIENT. THE SURGEON WAS GRASPING THE GALLBLADDER WHEN HE HEARD A SNAP SOUND COME FROM THE HANDLE. HE WAS ABLE TO RELEASE THE GALLBLADDER AT WHICH POINT A SECOND GRASPER WAS OPENED. THE SECOND GRASPER LOCKED UP WITHOUT TISSUE IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20932112 ↗
• MalfunctionDec 13, 2024Material Frayed; Material Frayed

  PROCEDURE PERFORMED: ROBOTIC LAR. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4), COMPLAINT 2 OF 2: (B)(4). [HOSPITAL] AFTER USING THIS INSTRUMENT FOR A PERIOD OF TIME, THE FRONT TIP WILL BECOME ADHESIVE TO TISSUES. CHANGING TO ANOTHER INSTRUMENT FOR USE WILL STILL RESULT IN ADHESION AT THE FRONT TIP, UNTIL THE THIRD GRASPER IS USED TO COMPLETE THE SURGERY. THERE IS NO IMPACT TO PATIENT. USER REPLACE WITH NEW GRASPER TO COMPLETE THIS SURGERY. THERE IS NO OTHER INSTRUMENTS TO AFFECT THIS EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 15AUG2023 VIA EMAIL FROM [DISTRIBUTOR]: INTESTINE TISSUE WAS BEING GRASPED AT THE TIME OF THE INCIDENT. INTERVENTION: USER REPLACE WITH NEW GRASPER TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE

  Patient problems: Physical Entrapment

  MAUDE report 20931951 ↗
• MalfunctionDec 13, 2024Material Frayed; Material Frayed

  PROCEDURE PERFORMED: ROBOTIC LAR. EVENT DESCRIPTION: COMPLAINT 1 OF 2: #: (B)(4). COMPLAINT 2 OF 2: #: (B)(4). [HOSPITAL]. AFTER USING THIS INSTRUMENT FOR A PERIOD OF TIME, THE FRONT TIP WILL BECOME ADHESIVE TO TISSUES. CHANGING TO ANOTHER INSTRUMENT FOR USE WILL STILL RESULT IN ADHESION AT THE FRONT TIP, UNTIL THE THIRD GRASPER IS USED TO COMPLETE THE SURGERY. THERE IS NO IMPACT TO PATIENT. USER REPLACE WITH NEW GRASPER TO COMPLETE THIS SURGERY. THERE IS NO OTHER INSTRUMENTS TO EFFECT THIS EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 15AUG2023 VIA EMAIL FROM [DISTRIBUTOR]: INTESTINE TISSUE WAS BEING GRASPED AT THE TIME OF THE INCIDENT. INTERVENTION: USER REPLACE WITH NEW GRASPER TO COMPLETE THIS SURGERY. PATIENT STATUS: FINE.

  Patient problems: Physical Entrapment

  MAUDE report 20931925 ↗
• MalfunctionDec 13, 2024Material Frayed; Material Frayed

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: SCRUB NURSE NOTICED LOOSE THREAD(S) ON LATIS PAD WHEN HANDED. THE DEVICE WAS SET ASIDE AND NOT USED FOR THE PROCEDURE. NO CLINICAL IMPACT TO THE PATIENT. OPENED A NEW GRASPER. INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931825 ↗
• MalfunctionDec 3, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PROCEDURE PERFORMED: NA EVENT DESCRIPTION: COMPLAINT (B)(4), COMPLAINT (B)(4). THE INFORMATION WAS COLLECTED AS FEEDBACK IN A MEETING WITH THE SURGEON. THE FEEDBACK SUBMISSION NUMBER IS 7139. THE DOCTOR SAID THAT THE LATIS PADS HAVE CHANGED SINCE THE MIM UPDATE. THEY ARE NOW 'LIKE SANDPAPER' AND HAS STOPPED USING THEM ALTOGETHER NOW. DR [NAME] WAS A HIGH-VOLUME USER PREVIOUSLY. ADDITIONAL INFORMATION WAS PROVIDED BY [NAME], AMA TERRITORY MANAGER VIA EMAIL ON 16-DEC-2024. "IT WAS JUST FEAR THE SURGEON HAD WHICH KEPT HIM FROM USING THE DEVICES." ADDITIONAL INFORMATION WAS PROVIDED BY [NAME], AMA TERRITORY MANAGER VIA EMAIL ON 23-DEC-2024. "YES, I REPLIED TO THIS ONE WITH THE SECOND COMPLAINT FOLLOW-UP. BOTH CASES DID NOT INVOLVE A PATIENT, THESE WERE JUST THE THOUGHTS OF BOTH SEPARATE SURGEONS ON EACH REPORT." PATIENT STATUS: NA INTERVENTION: NA

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

  MAUDE report 20838524 ↗
• MalfunctionDec 3, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PROCEDURE PERFORMED: NA EVENT DESCRIPTION: COMPLAINT (B)(4), COMPLAINT (B)(4). THE INFORMATION WAS COLLECTED AS FEEDBACK IN A MEETING WITH THE SURGEON. THE FEEDBACK SUBMISSION NUMBER IS 7138. SURGEON FELT THAT THE LATIS PADS ARE EXTREMELY ROUGH AND STICKY AND CAUSES 'HOLES IN THE BOWEL'. WILL NOT USE THEM AND CONTRAINDICATES THEIR USE IN COLORECTAL SURGERY. THE DEVICE WAS BEING USED FOR GRASPING BOWEL. POTENTIAL HOLES IN BOWEL. THIS IS A GENERIC COMPLAINT, REGARDING THE NEW ALTERATIONS TO THE GRASPER SINCE THE MIM UPGRADE WAS IMPLEMENTED. DOCTOR STATED THAT THIS WAS ABSOLUTELY NOT A DEVICE TO BE USED ON THE BOWEL DUE TO RISK OF TEARING. IT IS UNKNOWN IF THERE WAS ANY CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. IT IS UNKNOWN HOW THE USER RESOLVED THE SITUATION. ADDITIONAL INFORMATION WAS PROVIDED BY [NAME], (B)(4) TERRITORY MANAGER VIA EMAIL ON 16-DEC-2024. "IT WAS JUST A FEAR THE SURGEON HAD WHICH KEPT HIM FROM USING THE DEVICES." ADDITIONAL INFORMATION WAS PROVIDED BY [NAME], (B)(4) TERRITORY MANAGER VIA EMAIL ON 23-DEC-2024. "YES, I REPLIED TO THIS ONE WITH THE SECOND COMPLAINT FOLLOW-UP. BOTH CASES DID NOT INVOLVE A PATIENT, THESE WERE JUST THE THOUGHTS OF BOTH SEPA

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

  MAUDE report 20838179 ↗
• MalfunctionOct 3, 2024Material Separation; Material Separation

  PROCEDURE PERFORMED: LOWER ANTERIOR RESECTION WITH DA VINCI ROBOTIC SURGERY. EVENT DESCRIPTION: [HOSPITAL] "THE SURGEON DISCOVERED THAT THE TIP OF THE INSTRUMENT WAS BROKEN AND UNUSABLE UPON INITIAL USE." ADDITIONAL INFORMATION RECEIVED FROM [DISTRIBUTOR] VIA EMAIL ON 10SEP2024 "JAW DETACHED. MALFUNCTION NOTICED OR HAPPENED BEGINNING OF THE SURGERY." ADDITIONAL INFORMATION OBTAINED FROM [DISTRIBUTOR] VIA EMAIL ON 22NOV2024: AS THE INCIDENT OCCURRED LONG AGO, THE USER NO LONGER RECALLS THE DETAILS, AND THE UNIT HAS BEEN RETURNED TO APPLIED, MAKING IT IMPOSSIBLE FOR US TO VERIFY THE ISSUE. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359178 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC RIGHT HEMI-COLECTOMY. DESCRIPTION OF EVENT: IT WAS BEING USED TO GRASP TISSUE/SPECIMENS DURING THE PROCEDURE. THE PROCEDURE STARTED OFF AS A ROBOTIC CASE AND CONVERTED TO LAPAROSCOPIC DURING THE PROCEDURE. THEY NOTICED DURING THE PROCEDURE THAT THE LATIS PADS HAD COME AWAY FROM THE JAWS AND IT WAS SEEN ON THE CAMERA STACK. THE CUSTOMER WILL BE SENDING ME IMAGES OF THE ITEM AND I WILL UPLOAD THESE UPON RECEIPT OF THE IMAGES. REPLACED WITH ANOTHER C4140 AND NO PROBLEMS WITH THAT DEVICE, THE PROCEDURE WAS THEN COMPLETED ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 13AUG24: GRASPERS WERE USED TO GRASP TISSUE IN THE NORMAL WAY, NO DIFFERENT TO HOW THEY ALWAYS USE THE DEVICE. THE PAD WAS ALL RETRIEVED, BUT NOT BOTH PADS ON EITHER SIDE OF THE JAWS WAS DETACHED, JUST ONE SIDE, AS SHOWN IN THE IMAGES. INTERVENTION: REPLACED WITH ANOTHER C4140 AND NO PROBLEMS WITH THAT DEVICE, THE PROCEDURE WAS THEN COMPLETED PATIENT STATUS: NO INJURY TO THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072170 ↗
• InjuryAug 21, 2024Material Frayed; Material Frayed

  PROCEDURE PERFORMED: APPENDECTOMY EVENT DESCRIPTION: COMPLAINT CREATED BASED OFF OF MEDWATCH UF/IMPORTER REPORT # (B)(4). [HOSPITAL] "UPON USING EPIX LAPAROSCOPIC GRASPER (REF# C4130, LOT #1 512170), A THREAD ON THE PAD, AT THE TIP OF THE GRASPER BECAME CAUGHT UPON THE INTESTINES WHEN USING THE GRASPER, DURING REMOVAL OF THE APPENDIX. IRRITATION AND REDNESS SEEN WHERE THE THREAD WAS, UPON USAGE OF THE GRASPER. SURGEON ASSESSED THE AREA OF THE INTESTINES AND DETERMINED THAT THERE WAS NO ACTIVE BLEEDING AND PROCESSED WITH APPENDECTOMY." ADDITIONAL INFORMATION RECEIVED FROM [CUSTOMER] VIA EMAIL ON 30JUL2024: [HOSPITAL] DOES PURCHASE DEVICES DIRECTLY FROM AMR. THE DEPARTMENT NO LONGER HAS THE DEVICE, DEVICE WAS DISCHARGED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM [CUSTOMER] VIA EMAIL ON 30JUL2024: THE GRASPERS THAT THE HOSPITAL PURCHASES DO NOT COME AS PART OF A KIT. THE HOSPITAL PURCHASES APPLIED MEDICAL GRASPERS BY THE BOX, QTY (B)(4). ADDITIONAL INFORMATION RECEIVED FROM [CUSTOMER] VIA EMAIL ON 1AUG2024: THE COMPLAINT OCCURRED AT [HOSPITAL] WHICH IS UNDER [HOSPITAL]'S LICENSE. [HOSPITAL] IS [HOSPITAL]'S CAMPUS IN [LOCATION]. INTERVENTION: SURGEON

  Patient problems: Inflammation

  MAUDE report 20019033 ↗

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