Epix Laparoscopic Grasper C4130Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00607915110147), received between Feb 24, 2016 and Sep 23, 2026 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 7, 2024Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC SALPINGO OOPHORECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, THE SHAFT OF THE DEVICE WAS BENT. IT WAS NOTED AS A VISIBLE BREAK BUT WITH ALL PARTS INTACT. NO REMNANTS OF THE DEVICE FELL INTO THE PATIENT. THE CASE WAS COMPLETED WITH THE SAME DEVICE AND HAD NO OTHER PROBLEMS. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE. PRODUCT IS AVAILABLE FOR RETURN. PRODUCT UPDATED TO NPR: ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH #MW5147682 ON 29DEC2023: TODAY WE HAD A DISPOSABLE EPIX LAPAROSCOPIC GRASPER BREAK DURING USE. ALL PARTS OF THE INSTRUMENT ARE INTACT (VISIBLE BREAK), AND NO REMNANTS OF THE INSTRUMENT WERE FOUND OR LEFT IN THE PATIENT. PATIENT STATUS: NO PATIENT INJURY AND THE PATIENT IS DOING FINE. INTERVENTION: THE CASE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265509 ↗
• MalfunctionApr 10, 2024Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAP CHOLECYSTECTOMY EVENT DESCRIPTION: 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 [NAME] 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 [NAME] 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 JAWS AND WAS REMOVED. CASE WAS COMPLETED USING A THIRD GRASPER. THEY HAD ONE GRASPER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084022 ↗
• MalfunctionNov 9, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT 13-OCT-2023. COMPLAINT PRODUCT FAMILY: GRASPER, PRODUCT NAME: EPIX GRASPER, MODEL NUMBER: C4130, LOT NUMBER: 1468046. THE EVENT OCCURRED BEFORE USE OF THE DEVICE, FOR AN UNKNOWN PROCEDURE. THE NURSE HAD IDENTIFIED WHILST DOING SET-UP. IT WAS REPORTED THAT HAIR HAD BEEN FOUND INSIDE THE SEALED PACKAGE OF THE DEVICE. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF BEFORE USE OF THE PROCEDURE. THE USER RESOLVED THE SITUATION BY USING ANOTHER DEVICE FROM THE SHELF. NO OTHER INSTRUMENTS WERE USED WHEN THE COMPLAINT EVENT OCCURRED. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107291 ↗
• MalfunctionMar 22, 2023Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP GEN SURG EVENT DESCRIPTION: EVENT 1 OF 2: 2023-000613 [MFR #2027111-2023-00392] EVENT 2 OF 2: 2023-000614 [MFR #2027111-2023-00393] IN BOTH PROCEDURES THE DEVICES WERE BEING USED TO MOVE AND MANIPULATE INTERNAL ORGANS. BOTH PROCEDURES WHERE THE DEVICES FAILED WERE BEING USED BY DIFFERENT SURGEON. ONE INCIDENT WAS 6/8 WEEKS AGO AND THE OTHER WAS 2 WEEKS AGO. NO CHANGES IN HEALTH RESULTING FROM THE EVENT. ONE PROCEDURE ONE OF THE PADS FELL OFF AND WAS RETRIEVED BY THE DEVICE ITSELF. THE OTHER PROCEDURE THE DEVICE PAD/S STARTED TO FRAY AND AGAIN WAS RETRIEVED BY THE DEVICE. THE FRAYED PART IS INCLUDED IN THE GRASPER PACKAGING. NO DETAILS AVAILABLE ON WHAT OTHER INSTRUMENTS WERE USED WHEN THE COMPLAINT EVENT OCCURRED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 16MAR23: IT IS THE REPRESENTATIVE'S UNDERSTANDING THAT A WHOLE PAD CAME OFF AND WAS RETRIEVED. IT WAS NOT WITH THE DEVICE WHEN IT WAS GIVEN TO THE REPRESENTATIVE. ADDITIONAL INFORMATION RECEIVED FROM IRIC IN SCOTLAND 23MAR23: THE EVENT HAPPENED ON MARCH 1, 2023. APPLIED MEDICAL 'PAD' FRAYED DURING USE ON PATIENT. POTENTIAL FOR FRAYED THREADS TO GET LOST INSIDE THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594365 ↗
• MalfunctionMar 22, 2023Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP GEN SURG EVENT DESCRIPTION: EVENT 1 OF 2: 2023-000613 [MFR #2027111-2023-00392] EVENT 2 OF 2: 2023-000614 [MFR #2027111-2023-00393] IN BOTH PROCEDURES THE DEVICES WERE BEING USED TO MOVE AND MANIPULATE INTERNAL ORGANS. BOTH PROCEDURES WHERE THE DEVICES FAILED WERE BEING USED BY DIFFERENT SURGEON. ONE INCIDENT WAS 6/8 WEEKS AGO AND THE OTHER WAS 2 WEEKS AGO. NO CHANGES IN HEALTH RESULTING FROM THE EVENT. ONE PROCEDURE ONE OF THE PADS FELL OFF AND WAS RETRIEVED BY THE DEVICE ITSELF. THE OTHER PROCEDURE THE DEVICE PAD/S STARTED TO FRAY AND AGAIN WAS RETRIEVED BY THE DEVICE. THE FRAYED PART IS INCLUDED IN THE GRASPER PACKAGING. NO DETAILS AVAILABLE ON WHAT OTHER INSTRUMENTS WERE USED WHEN THE COMPLAINT EVENT OCCURRED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 16MAR23: IT IS THE REPRESENTATIVE'S UNDERSTANDING THAT A WHOLE PAD CAME OFF AND WAS RETRIEVED. IT WAS NOT WITH THE DEVICE WHEN IT WAS GIVEN TO THE REPRESENTATIVE. INTERVENTION: ZERO ISSUES PATIENT STATUS: RETRIEVED BY THE DEVICE ITSELF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593787 ↗
• MalfunctionFeb 16, 2023Entrapment of Device; Material Frayed; Material Split, Cut or Torn; Physical Resistance/Sticking; Entrapment of Device; Material Frayed; Material Split, Cut or Torn; Physical Resistance/Sticking

  PROCEDURE PERFORMED: APPENDECTOMY. EVENT DESCRIPTION: TODAY (ON (B)(6) 2023) I GOT ANOTHER CER FROM THE SAME HOSPITAL. THE JAWS OF THE GRASPING FORCEPS STUCK TO THE TISSUE SEVERAL TIMES DURING THE PROCEDURE. ONE SUSPECTS AN UNCLEANLY MANUFACTURED JAWS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE CONFIRMED IN PERSON ON (B)(6) 2023: THE CUSTOMER IS RETURNING THE DEVICE. INCIDENTS (B)(4) ARE IDENTICAL IN TERMS OF HOW THE JAWS WERE STUCK TO THE TISSUE. STITCHED OVER THE TISSUE FOR SECURITY. THE TISSUE CAME LOOSE AFTER SEVERAL ATTEMPTS TO PULL ON IT. INTERVENTION: STITCHED OVER THE TISSUE FOR SECURITY. THE TISSUE CAME LOOSE AFTER SEVERAL ATTEMPTS TO PULL ON IT. PATIENT STATUS: NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387990 ↗
• MalfunctionDec 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NAME OF PROCEDURE BEING PERFORMED: UNSURE. DETAILED DESCRIPTION OF EVENT: AS PER ATTACHED FORM FILLED OUT BY NURSE ATTENDING, PART OF THE DEVICE CAME OFF IN PATIENT. QUALITY REPORT FORM FROM HOSPITAL STATES THAT SMALL PIECE DETACHED FROM GRASPER TIP. PATIENT STATUS: NO ADVERSE EVENT FOR PATIENT. TYPE OF INTERVENTION: SURGEON HAD TO LOCATE THE LOST PIECE FROM ABDOMEN - NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929608 ↗
• MalfunctionNov 7, 2021Flaked; Flaked

  NAME OF PROCEDURE BEING PERFORMED: LAP CHOLE DETAILED DESCRIPTION OF EVENT: I WAS ASKED BY A SURGEON TO CONTACT YOU ABOUT ONE OF YOUR PRODUCTS. WE WERE USING THE "EPIX LAPAROSCOPIC GRASPER" REF# (B)(4) TODAY FOR A LAP CHOLE. THE SURGEON STATED THAT THE GREEN SHAFT OF THE INSTRUMENT WAS FLAKING MATERIAL OFF INTO THE PATIENT. SMALL HAIR LIKE GREEN FIBERS OR PAINT OR SOMETHING WAS FLAKING OR COMING OFF OF THE SHAFT OF THE INSTRUMENT AND WAS ENDING UP INSIDE OF HER PATIENT." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 11OCT2021 FROM [NAME], [FACILITY] SERVICE COORDINATOR: THE STRANDS WERE REMOVED FROM THE PATIENT. THE FOLLOWING INFORMATION IS FROM THE SURGEON OF THE CASE. THE PATIENT WAS A THIN, YOUNG GIRL GOING IN FOR AN ELECTIVE CASE. [...] I HAVE USED THEIR INSTRUMENTS A LOT BEFORE AND THERE WAS NO TORQUE, EXCESS FORCE ETC WITH HER CASE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 11OCT2021 FROM [NAME], [FACILITY] SERVICE COORDINATOR: PHOTO OF THE DEVICE HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 22OCT2021 FROM (B)(6). (ENTERED BY (B)(4)) THERE IS NO PATIENT INJURY AT THIS TIME. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 02NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763640 ↗
• MalfunctionAug 4, 2021Break; Break

  NAME OF PROCEDURE BEING PERFORMED: ROBOTIC LAPAROSCOPIC RECTOPEXY DETAILED DESCRIPTION OF EVENT: THE REP WAS NOT PRESENT DURING THE CASE. DURING THE CASE THE ASSISTANT WAS MOVING THE GRASPER UP THE SIGMOID COLON WHILE THE ROBOT ARM WAS MOVING DOWN THE SIGMOID COLON. DURING THE COURSE OF THIS MOVEMENT, THE GRASPER JAWS AND A PORTION OF THE GREEN SHAFT BROKE AND FELL INTO THE PATIENT. THE ENTIRE DEVICE, INCLUDING THE PORTION THAT BROKE OFF, WAS REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH THE OTHER GRASPER ALREADY IN USE DURING THE CASE. NO HARM TO PATIENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 13JUL2021 FROM [NAME]: CONTACT INFORMATION FOR FACILITY CONTACT HAS BEEN PROVIDED. PHOTOS OF THE DEVICE HAVE BEEN PROVIDED. PATIENT STATUS: NO HARM TO PATIENT. TYPE OF INTERVENTION: USED OTHER GRASPER IN THE CASE TO COMPLETE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278392 ↗
• MalfunctionOct 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  TYPE OF PROCEDURE PERFORMED: VNOTES HYSTERECTOMY+BILATERAL SALPINGECTOMY. [NAME] WAS DOING A VNOTES CASE, AND TOWARDS THE END OF THE CASE ON THE SCREEN WE NOTICED THE GRASPER WAS SCISSORING. THE GRASPER WAS REMOVED AND SHE CONTINUED THE CASE WITH A REUSABLE GRASPER FROM THE TRAY. THE PATIENT WAS NO HARMED. [NAME] WAS NOT CONCERNED DURING OR AFTER THE CASE. IT WAS THE FIRST TIME SHE HAD SEEN THIS WITH THE APPLIED MEDICAL GRASPER. PATIENT STATUS: PATIENT IS FINE AND COMPLETELY UNAFFECTED. TYPE OF INTERVENTION: PRODUCT WAS REPLACED WITH ANOTHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722955 ↗
• MalfunctionOct 20, 2020Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAP CHOLE. CER 1 OF 2: (B)(4). CER 2 OF 2: (B)(4). A SECOND EPIX GRASPER WITH SAME LOTNUMBER WAS USED AFTER ISSUES WITH THE FIRST ONE THAT WAS USED (SEE PRECIOUS CER OF SAME DATE). EPIX GRASPER JAWS WERE LOCKED ON THE GALLBLADDER, EXPERIENCED DIFFICULTY TO UNLOCK THE JAWS. AFTER SEVERAL GRIP ACTIONS THEY SUCCEEDED TO UNLOCK THE JAWS. INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10708579 ↗
• MalfunctionOct 15, 2020Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAP CHOLE. CER 1 OF 2: (B)(4). CER 2 OF 2: (B)(4). GRASPERS JAWS WERE LOCKED ON GALLBLADDER BUT THE GRASPER WOULD NOT UNLOCK. JAWS WERE UNLOCKED AFTER SEVERAL GRIP ACTIONS. GRASPER WAS DISCARDED & NEW EPIX GRASPER WAS USED WITH WHICH THEY HAD A VERY SIMILAR EXPERIENCE (SEPERATE CER). THIS EPIX GRASPER HAD THE SAME LOTNUMBER. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10687290 ↗
• InjuryMar 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PROCEDURE PERFORMED: LAP SUBTOTAL HYSTERECTOMY AND BSO. PATIENT DETAILS: FEMALE; DOB (B)(6). DR [NAME] WAS ASSISTING DR [NAME] CASE IN A LAP SUBTOTAL HYSTERECTOMY AND BSO; WHILST USING THE GRASPER A SMALL AMOUNT OF SMALL BOWEL WAS CAUGHT IN-BETWEEN THE HINGE OF THE EPIX GRASPER TIPS WHEN THE JAWS WERE OPEN AND SURGEON FOUND IT DIFFICULT TO DISLODGE ENTRAPPED TISSUE AND SOME BLEEDING OCCURRED SUGGESTING SMALL INJURY OCCURRED TO THE SMALL BOWEL. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM ADVANCED PROCEDURE SPECIALIST, [NAME] ON 14FEB2020: I HAVE SPOKEN TO [NAME] ABOUT THIS AND UNFORTUNATELY CANNOT CONFIRM THE BELOW. INTERVENTION: NI. PATIENT STATUS: STABLE.

  Patient problems: Bowel Perforation

  MAUDE report 9803203 ↗