Epix Laparoscopic Scissors CB040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607915110130), received between Mar 6, 2017 and Mar 1, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Failure to Cut; Failure to Cut

  NAME OF PROCEDURE BEING PERFORMED: GASTRIC SLEEVE REVISION. DETAILED DESCRIPTION OF EVENT: CB040 BLADES WERE DULL AND WOULD NOT CUT DOWN ADHESIONS DURING USE IN A PROCEDURE. CASE WAS COMPLETED WITH ANOTHER PAIR OF SCISSORS WITHOUT PROBLEM. NO PATIENT INJURY OCCURRED. PRODUCT IS AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: CASE WAS COMPLETED WITH ANOTHER PAIR OF SCISSORS WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13641095 ↗
• MalfunctionJan 3, 2022Failure to Cut; Failure to Cut

  NAME OF PROCEDURE BEING PERFORMED: LAP BAND REMOVAL. DETAILED DESCRIPTION OF EVENT: COMPANY REPRESENTATIVE WAS NOT PRESENT DURING THE CASE WHEN 3 EA. UNITS OF CB040 WOULD NOT CUT DURING USE. IT IS REPORTED THAT THE SCISSORS FUNCTIONED PROPERLY WHEN TESTED OUTSIDE OF THE PATIENT, BUT WHEN PLACED THROUGH THE TROCAR EACH UNIT OF SCISSORS WOULD NOT CUT. CASE WAS COMPLETED WITH A CB030. THERE WAS NO INJURY TO THE PATIENT. THE MATERIALS MANAGER ALSO REPORTS THAT THEY ARE UNSURE IF INCREASED CALCIFICATION ON THE LAP BAND ATTRIBUTED TO THE SCISSORS NOT CUTTING. WHEN THE SCISSORS WERE EXAMINED AFTER THE CASE, IT WAS REPORTED THAT THE BLADES HAD BURRS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 10D-EC-2021 FROM [NAME], ACCOUNT MANAGER: IMAGE OF COMPLAINT DEVICE SHOWING BURR ON BLADES. REP STATES THAT ALL 3 UNITS HAVE THE BURR. CUSTOMER STATES THAT WHEN THE SCISSORS WERE TAKEN OUT OF THE PACKAGE, THEY WORKED. BUT ONCE THERE WERE IN THE PORT TO CUT THE BAND, THEY "LOCK UP." THIS HAPPENED WITH ALL 3 SCISSORS, AND EACH WERE TESTED BEFOREHAND. "THE SMALLER SCISSOR WORKED. I OPENED ANOTHER ONE AND IT WORKS OUT OF THE PACKAGE BUT WHEN ANY PRESSURE IS PUT ON THE SHAFT IT WONT WORK." PRODUCTS ARE AVAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13146270 ↗
• MalfunctionJan 3, 2022Failure to Cut; Failure to Cut

  NAME OF PROCEDURE BEING PERFORMED: LAP BAND REMOVAL DETAILED DESCRIPTION OF EVENT: COMPANY REPRESENTATIVE WAS NOT PRESENT DURING THE CASE WHEN 3 EA. UNITS OF CB040 WOULD NOT CUT DURING USE. IT IS REPORTED THAT THE SCISSORS FUNCTIONED PROPERLY WHEN TESTED OUTSIDE OF THE PATIENT, BUT WHEN PLACED THROUGH THE TROCAR EACH UNIT OF SCISSORS WOULD NOT CUT. CASE WAS COMPLETED WITH A CB030. THERE WAS NO INJURY TO THE PATIENT. THE MATERIALS MANAGER ALSO REPORTS THAT THEY ARE UNSURE IF INCREASED CALCIFICATION ON THE LAP BAND ATTRIBUTED TO THE SCISSORS NOT CUTTING. WHEN THE SCISSORS WERE EXAMINED AFTER THE CASE, IT WAS REPORTED THAT THE BLADES HAD BURRS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 10DEC2021 FROM [NAME], ACCOUNT MANAGER: IMAGE OF COMPLAINT DEVICE ATTACHED SHOWING BURR ON BLADES. REP STATES THAT ALL 3 UNITS HAVE THE BURR. CUSTOMER STATES THAT WHEN THE SCISSORS WERE TAKEN OUT OF THE PACKAGE, THEY WORKED. BUT ONCE THERE WERE IN THE PORT TO CUT THE BAND, THEY "LOCK UP." THIS HAPPENED WITH ALL 3 SCISSORS, AND EACH WERE TESTED BEFOREHAND. "THE SMALLER SCISSOR WORKED. I OPENED ANOTHER ONE AND IT WORKS OUT OF THE PACKAGE BUT WHEN ANY PRESSURE IS PUT ON THE SHAFT IT WONT WORK." PRODUCTS AR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13146267 ↗
• MalfunctionJan 3, 2022Failure to Cut; Failure to Cut

  NAME OF PROCEDURE BEING PERFORMED: LAP BAND REMOVAL. DETAILED DESCRIPTION OF EVENT: COMPANY REPRESENTATIVE WAS NOT PRESENT DURING THE CASE WHEN 3 EA. UNITS OF CB040 WOULD NOT CUT DURING USE. IT IS REPORTED THAT THE SCISSORS FUNCTIONED PROPERLY WHEN TESTED OUTSIDE OF THE PATIENT, BUT WHEN PLACED THROUGH THE TROCAR EACH UNIT OF SCISSORS WOULD NOT CUT. CASE WAS COMPLETED WITH A CB030. THERE WAS NO INJURY TO THE PATIENT. THE MATERIALS MANAGER ALSO REPORTS THAT THEY ARE UNSURE IF INCREASED CALCIFICATION ON THE LAP BAND ATTRIBUTED TO THE SCISSORS NOT CUTTING. WHEN THE SCISSORS WERE EXAMINED AFTER THE CASE, IT WAS REPORTED THAT THE BLADES HAD BURRS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 10DEC2021 FROM [NAME], ACCOUNT MANAGER: IMAGE OF COMPLAINT DEVICE ATTACHED SHOWING BURR ON BLADES. REP STATES THAT ALL 3 UNITS HAVE THE BURR. CUSTOMER STATES THAT WHEN THE SCISSORS WERE TAKEN OUT OF THE PACKAGE, THEY WORKED. BUT ONCE THERE WERE IN THE PORT TO CUT THE BAND, THEY "LOCK UP." THIS HAPPENED WITH ALL 3 SCISSORS, AND EACH WERE TESTED BEFOREHAND. "THE SMALLER SCISSOR WORKED. I OPENED ANOTHER ONE AND IT WORKS OUT OF THE PACKAGE BUT WHEN ANY PRESSURE IS PUT ON THE SHAFT IT WONT WORK." PRODUCTS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13146265 ↗
• MalfunctionSep 7, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: STAFF THOUGHT THAT THE PACKAGING HAD A HOLE IN IT, LOOKS LIKE IT WAS MELTED. THERE WAS NO RISK OR IMPACT ASSOCIATED WITH THIS COMPLAINT, THERE WAS NO DELAY TO CASE AND ANOTHER DEVICE WAS OPENED. THE PRODUCT IS USED WEEKLY; THE PRODUCT FOR RETURN IS NOT CONTAMINATED AND READY FOR COLLECTION BY THE REP. THE REP HAS NOTIFIED THE HOSPITAL OF THE "INDENTATION" AS BEING PART OF THE PACKAGING TO HOLD THE DEVICE UPRIGHT AND DOES NOT COMPROMISE STERILITY. TYPE OF INTERVENTION: ANOTHER DEVICE OPENED PATIENT STATUS: FINE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6850630 ↗
• MalfunctionMar 6, 2017Failure to Cut; Failure to Cut

  ROUX-EN-Y - "BLADES WERE NOT CUTTING." PATIENT STATUS - "PATIENT IS GOOD."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6380690 ↗