Epix Laparoscopic ScissorsRecalls & reported problems across all models

We found 2 models of Epix Laparoscopic Scissors by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 245 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2016 and May 20, 2024 — classified as 1 injury, 244 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (154 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 Scissors problems

Epix Laparoscopic Scissors models

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

• Epix Laparoscopic Scissors CB030

  Laparoscope, Gynecologic (And Accessories)
  239 reports
• Epix Laparoscopic Scissors CB040

  Laparoscope, Gynecologic (And Accessories)
  6 reports

Recent Epix Laparoscopic Scissors adverse event reports

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

• MalfunctionMay 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  TYPE OF PROCEDURE: LAPAROSCOPIC UMBILICAL HERNIA REPAIR. EVENT DESCRIPTION: HOSPITAL: [HOSPITAL NAME]. PRODUCT: CB030. "SURGEON WAS USING CB030 FOR MONOPOLAR COAGULATION, AND HE FELT THE CURRENT LEAKING. THE INSULATION WAS BROKEN." PRODUCT AVAILABLE FOR RETURN. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: USED ALTERNATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354854 ↗
• MalfunctionOct 24, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE). DETAILED DESCRIPTION OF EVENT: CONSUMABLE WAS CONTAMINATED AS THERE WAS A BREAK OF STERILITY BY ANOTHER CONSUMABLE THAT WAS PLACED ON TOP OF IT AND THE STERILE FIELD. CONSUMABLE NOT USED ON PATIENT. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. OPEN ANOTHER PACK TO RESOLVE THE SITUATION. TYPE OF INTERVENTION: OPEN ANOTHER PACK. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996353 ↗
• MalfunctionJul 31, 2023Failure to Deliver Energy; Failure to Deliver Energy

  PROCEDURE PERFORMED: ROBOTIC HERNIA REPAIR. EVENT DESCRIPTION: THE SURGEON WAS USING THE SCISSORS WITH MONOPOLAR ENERGY. THE DEVICE DID NOT WORK WHEN THEY PRESSED THE PEDAL. THEY REMOVED THE SCISSORS FROM THE MONOPOLAR CORD AND UNPLUGGED THE DEVICE. A METAL PIECE CAME OUT IN THE AREA THAT CONNECTS THE CORD AND SCISSORS AROUND THE HANDLE. THE CASE WAS COMPLETED WITH THE NEW DEVICE. NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 14AUG2023 FROM [NAME], ACCOUNT MANAGER I, APPLIED MEDICAL "THE DEVICE¿S LOT NUMBER IS 1485379." PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425986 ↗
• MalfunctionJul 12, 2023Sparking; Sparking

  PROCEDURE PERFORMED: INGUINAL HERNIA. EVENT DESCRIPTION: FIRE AND SMOKE CAME OUT OF THE SCISSOR. DR [NAME REDACTED] TOOK ANOTHER CB030 AND FINISHED THE PROCEDURE WITHOUT ANY PROBLEM. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 29JUN23: BY FIRE, IT MEANS SPARKS AT THE FIRST ACTIVATION AND IMMEDIATELY STOPPED USING IT. THE SMOKE ORIGINATED FROM THE SHAFT. THE SPARKS/SMOKE DID NOT CAUSE DAMAGE TO TISSUE. THERE WERE NO OTHER INSTRUMENTS IN THE SURGICAL FIELD WHEN THE EVENT OCCURRED. 3 METER CABLE OF [BRAND NAME REDACTED] WAS BEING USED TO CONNECT THE SCISSORS TO THE MONOPOLAR GENERATOR. SMOKE HAPPENED AFTER CAUTERY ACTION. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 30JUN23: NO DAMAGE NOTICED TO THE INSULATION. THE SPARKS OCCURRED BETWEEN MIDDLE AND PROXIMAL END OF THE SHAFT. THE SPARKS DID NOT COME INTO CONTACT WITH ANY NON-TARGET TISSUE. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17308910 ↗
• MalfunctionJun 12, 2023Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: DESIGN VALIDATION ACTIVITIES EVENT DESCRIPTION: JAWS ARE A LITTLE TIGHT. FEELS LIKE A 2 STEP PROCESS. FEELS LIKE THEY NEED TO BE OILED. FEEDBACK PROVIDED BY [NAME] DURING SCISSORS DESIGN VALIDATION. PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 12MAY2023 VIA EMAIL FROM [NAME], CLINICAL DEVELOPMENT ANALYST: COMPLAINT CREATED BASED OFF FEEDBACK 5242. SUBMITTED 22MAR2023 DEVICE WAS USED ON PORCINE TISSUE DURING DESIGN VALIDATION AT (B)(6) CENTER. NO ISSUES COMPLETING TESTING. THE DEVICE WAS FUNCTIONAL UPON INITIAL USE. THE USER WAS CUTTING STOMACH BLOOD VESSEL WHEN ROUGH BLADE ACTUATION WAS NOTICED. PATIENT STATUS: DEVICE WAS USED ON PORCINE TISSUE. INTERVENTION: NO ISSUES COMPLETING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110164 ↗
• MalfunctionJan 10, 2023Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [INSTITUTION]. REPORT FROM THE SALES REP. WHEN THE SCISSORS WERE INSERTED FROM THE TROCAR, THE SCISSORS WAS STUCK OPEN IN THE ABDOMINAL CAVITY AND WOULD NOT RETURN. THE CASE WAS COMPLETED WITH THE NEW ONE. INITIAL INVESTIGATION REPORT: THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. A PART OF THE BLADE WAS SHAVED AND BURRED. (PIC.1) AFTER REMOVING THE BURRS, IT COULD BE OPENED AND CLOSED, ALTHOUGH IT WAS STUCK. THE UNITS WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(6). PRODUCTS AVAILABLE FOR RETURN: 1 PACKAGE, 1 SCISSORS. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132549 ↗
• MalfunctionDec 2, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: NEPHRECTOMY. EVENT DESCRIPTION: [INSTITUTION] REPORT FROM THE SALES REP IT WAS HARD AND DIFFICULT TO OPEN THE SCISSORS DURING THE PROCEDURE. COMPLETED THE PROCEDURE BY SWITCHING TO ANOTHER PRODUCT. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THERE WERE NO SCRATCHES OR ABNORMALITIES ON THE BLADE (PIC.1). THE UNITS WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. PRODUCTS AVAILABLE FOR RETURN: 1 PACKAGE, 1 SCISSORS PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: COMPLETED THE PROCEDURE BY SWITCHING TO ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15901621 ↗
• MalfunctionNov 9, 2022Material Deformation; Mechanical Jam; Scratched Material; Material Deformation; Mechanical Jam; Scratched Material

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) [MFR #2027111-2022-00809] COMPLAINT 2 OF 2: (B)(4) [MFR #2027111-2022-00810] REPORT FROM THE SALES REP THE DOCTOR WAS TRIED TO RESECT THE TISSUE USING CB030 DURING THE PROCEDURE, BUT THE SCISSORS DID NOT CLOSE. THE DOCTOR SWITCHED TO THE SAME PRODUCT, BUT THE SCISSORS DID NOT CLOSE THE SECOND ONE AS WELL. COMPLETED THE PROCEDURE BY SWITCHING TO ANOTHER PRODUCT. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. THERE WERE SCRATCHES ON THE MEDIAL OF THE BLADE. THERE WAS A SCRATCH ON THE DISTAL OF THE BLADE. THE UNITS WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. PRODUCT AVAILABLE FOR RETURN: 1 SCISSORS. PATIENT STATUS: "NO PATIENT INJURY" INTERVENTION: "THE DOCTOR SWITCHED TO THE SAME PRODUCT, BUT THE SCISSORS CLOSE THE SECOND ONE AS WELL. COMPLETED THE PROCEDURE BY SWITCHING TO ANOTHER PRODUCT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762141 ↗
• MalfunctionNov 2, 2022Failure to Deliver Energy; Failure to Deliver Energy

  PROCEDURE PERFORMED: HYSTEROMYOMECTOMY. EVENT DESCRIPTION: [USER FACILITY] "SURGEON CONNECT THIS UNIT TO ESU BUT IT IS NOT ENERGIZED. THEY TRY TO CHANGE THE CABLE AND EQUIPMENT. THIS UNIT IS STILL NOT WORKING." EXPECT PRODUCT RETURN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 20OCT2022 FROM [NAME], PURCHASING REPRESENTATIVE, [DISTRIBUTOR] THE CAUTERY FUNCTION DOESN'T WORK. A [COMPETITOR] MONOPOLAR CORD WAS USED. THE CORD WAS ABLE TO BE ATTACHED TO THE DEVICE. THE CABLE WAS REPLACED WITH AN ALTERNATE DEVICE. THIS DID NOT PROVIDE A RESOLUTION. THERE ARE NO PICTURES AVAILABLE. NO OTHER INSTRUMENTS WERE USED DURING THE PROCEDURE. PATIENT STATUS: "FINE." INTERVENTION: "THEY TRY TO CHANGE THE CABLE AND EQUIPMENT. THIS UNIT IS STILL NOT WORKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715287 ↗
• MalfunctionOct 11, 2022Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC MYOMECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE THE SCISSORS HANDLE GOT JAMMED, WE HAD TO OPEN A NEW DEVICE (CB030) AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR VIA EMAIL 19SEP22: THE DEVICE WAS DIFFICULT TO ACTUATE FROM THE BEGINNING WHEN DR TRIES TO OPEN JAWS ONCE ENTERING PATIENT. HANDLE JAMMED REPEATEDLY. THE DEVICE WAS NON-FUNCTIONAL UPON INITIAL USE. THE USER WAS CUTTING ADHESIONS WITHIN THE ABDOMEN FROM PREVIOUS LAP SURGERY. INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: PATIENT WAS NOT HURT, ONLY THAT THE SCISSORS HANDLE JAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577507 ↗
• MalfunctionAug 30, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: [NAME] PROVIDED THE FOLLOWING INFORMATION VIA EMAIL ON 9 AUGUST 2022: WE HAVE RECEIVED A CER COMPLAINT FROM [USER FACILITY]. CALL WAS MADE TO CUSTOMER RELATIONS TEAM YESTERDAY FROM [NAME]. THIS IS ALL OF THE INFORMATION HE HAS AND I DO NOT HAVE ANY MORE INFORMATION AT THIS STAGE FROM THEATRES: PRODUCT CODE: CB030. LOT: 1453534. DATE OF ISSUE: (B)(6) 2022. ISSUE: SCISSORS WERE NOT CLOSING PROPERLY. PROCEDURE AND SURGEON IS UNKNOWN. CN SUBMITTED THE FORM BUT PERSON IS UNKNOWN AT THIS STAGE ¿ SIGNATURE ONLY APPEARS WITHOUT NAME PRINTED ON FORM. LIMITED INFORMATION HAS BEEN RECEIVED BY MATERIALS MANAGEMENT TEAM HOWEVER THEY HAVE THE PRODUCT IN A BAG READY TO BE PICKED UP. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [NAME] ON 15AUG2022: THE SCISSOR BLADES WOULD GET CAUGHT AND NOT OPEN PROPERLY. THE PATIENT WAS NOT AFFECTED. THEY USED ANOTHER ONE EXACTLY THE SAME WITH NO PROBLEM. INTERVENTION: THEY USED ANOTHER ONE EXACTLY THE SAME WITH NO PROBLEM. PATIENT STATUS: THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325020 ↗
• MalfunctionJul 22, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: SCISSORS BLOCKED AFTER SEVERAL CUTS. USED ANOTHER PAIR OF SCISSORS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2022: THE ONLY THING I GET AS EXTRA INFORMATION IS THAT THE CUTTING MECHANISM OF THE SCISSORS DIDN¿T WORK SMOOTHLY. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: THEY WERE NOT ABLE TO OPEN THE SCISSORS. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089882 ↗
• MalfunctionJun 21, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE: GASTRECTOMY. EVENT DESCRIPTION: [USER FACILITY] THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO.(B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. REPORT FROM THE SALES REP THE OPENING AND CLOSING OF THE BLADE BECAME HEAVIER AND HARDER TO CLOSE IN THE MIDDLE OF THE PROCEDURE. THE CASE WAS COMPLETED WITH THE NEW ONE. INITIAL INVESTIGATION REPORT THE EVENT UNIT WAS RETURNED TO US AND VISUALLY INSPECTED. WHEN THE HANDLE WAS OPENED, THE BLADE TIPS APPEARED TO BE CROSSED AND IN EXCESSIVE CONTACT (PIC.1) THE UNITS WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4). PRODUCTS AVAILABLE FOR RETURN: 1 PACKAGE, 1 SCISSORS. INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760378 ↗
• MalfunctionJun 21, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: WHEN TRYING MANEUVER DEVICE IT FELT STIFF/DIFFICULT AND ALSO SEEMS BLUNT (DIFFICULT TO CUT TISSUE). USER REPLACED DEVICE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM [NAME] ON 10 JUNE 2022: 1. PATIENT STATUS FOLLOWING THE PROCEDURE: I AM UNABLE TO OBTAIN ANY FURTHER INFORMATION. 2. NAME OF PROCEDURE BEING PERFORMED: I AM UNABLE TO OBTAIN ANY FURTHER INFORMATION. 3. REASON WHY THE PRODUCT IS NOT RETURNING FOR INVESTIGATION: IT HAS BEEN DISPOSED. INTERVENTION: REPLACED. PATIENT STATUS: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14757765 ↗
• MalfunctionJun 9, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR]. INCOMING INSPECTION PO# (B)(4). THIS IS A COMPLAINT FROM [DISTRIBUTOR] EVALUATION TEAM. THE LOT MENTIONED ABOVE WAS FOUND TO HAVE DEFECTIVE UNITS PER OUR INCOMING INSPECTION. DELIVERY DATE: (B)(6) 2022. WE FOUND DEFECTS AS THE RESULT OF INCOMING INSPECTION OF THE PRODUCTS. PLEASE REFER TO THE ATTACHMENT MATERIAL FOR THE QUANTITY WHICH RETURNS THE PRODUCTS. WE FOUND THE DEFECTS THAT ALREADY INFORMED APPLIED MEDICAL BY CER. WE JUST INFORM YOU THE DEFECT AND RETURN THE PRODUCTS FOR FOLLOWING DEFECTS. YOU DO NOT NEED INVESTIGATION. HAIRLIKE OBJECT IN POUCH - CB030 LOT #1446046 (1 EA.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645317 ↗

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