Epix Laparoscopic Grasper C4140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915110154), received between Jun 26, 2020 and Aug 4, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionOct 5, 2022Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC COLOSTOMY TAKEDOWN WITH ANASTOMOSIS. GREEN PLASTIC LOCATED ON SHAFT BROKE OFF AND FELL INTO THE PATIENT DURING CASE. THE AREA THAT BROKE OFF WAS ABOUT 1 CM INTO THE GREEN PLASTIC PORTION DISTAL TO THE TIP OF THE DEVICE. SURGEON WAS ABLE TO RETRIEVE ALL PLASTIC PIECES. NO PATIENT INJURY OCCURRED. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: SURGEON WAS ABLE TO RETRIEVE ALL PLASTIC PIECES. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545219 ↗
• MalfunctionJun 26, 2020Fracture; Fracture

  PROCEDURE PERFORMED: COLORECTAL PROCEDURE I WAS INFORMED BY THE HOSPITAL THAT LAST TUESDAY ((B)(6)) [SURGEON NAME REMOVED] WAS USING OUR C4140 GRASPERS FOR A CASE WHEN HE NOTICED AT THE START OF THE CASE THAT THERE WAS A "CRACK" TOWARDS THE DISTAL END OF THE GREEN GRASPER SHAFT. NOTHING OUT OF THE ORDINARY HAD OCCURRED PRIOR TO USING THE GRASPERS AND NOTHING WAS KNOWN TO HAVE COME INTO CONTACT WITH THE GRASPER THAT MAY HAVE CAUSED THE CRACK. UPON VISITING THE HOSPITAL TO INSPECT THE INCIDENT UNITS THE CRACK WAS VISIBLE AND LOOKED TO BE WITHIN THE SAME MARGIN OF THE PROTECTIVE GUARD THAT COMES AS PART OF THE PACKAGING TO PROTECT THE TIP OF THE GRASPERS. NO PATIENT INJURY OCCURRED AS A RESULT OF THIS INCIDENT HOWEVER THERE IS ONGOING CONCERN THAT THE MATERIAL MAY STILL BE WITHIN THE PATIENT'S BODY AS IT IS NOT IDENTIFIABLE VIA X-RAY. ADDITIONAL INFORMATION RECEIVED FROM USER FACILITY VIA TELEPHONE 28APR2020: DEVICE WAS DISCARDED FOLLOWING VISIT FROM TERRITORY MANAGER DUE TO CONTAMINATION AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION RECEIVED FROM SALES MANAGER VIA TELEPHONE 12JUN2020: I SPOKE WITH THE SALES MANAGER EARLIER TODAY - HE CALLED THE CUSTOMER ON THURSDAY AND CONFIRMED T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10204119 ↗