Epix Laparoscopic Scissors CB030Recalls & reported problems

Summary

The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 00607915110123), received between Apr 4, 2016 and May 20, 2024 — classified as 1 injury, 238 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (149 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 239 reports, 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 ↗
• MalfunctionJun 6, 2022Difficult to Open or Close; Material Deformation; Mechanical Jam; Difficult to Open or Close; Material Deformation; Mechanical Jam

  PROCEDURE PERFORMED: NA (STERILE UNIT RETURNED). EVENT DESCRIPTION: COMPLAINT 1 OF 4: (B)(4)., MFR #2027111-2022-00533. COMPLAINT 2 OF 4: (B)(4). COMPLAINT 3 OF 4:(B)(4). COMPLAINT 4 OF 4: (B)(4). WHILE THE SURGEON WAS TRYING TO CUT USING APPLIED MEDICAL SCISSORS, THE DEVICE BLOCKED THE JAWS. THE SCISSOR NO LONGER OPENED, LOCKING ALSO IN THE HANDLE. THE SURGEON ALSO HAD DIFFICULTY REMOVING THE DEVICE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 16MAR2022: YES, THE DOES NOT WORK UPON INITIAL USE JUST AFTER A FEW MINUTES OF USE THE SCISSORS DID NOT OPEN ANYMORE. THE BLADES DID NOT OPEN/CLOSE FULLY AT THE BEGINNING. THE SCISSORS WERE NOT USED TO CUT STAPLES/ LAPBAND/DENSE TISSUE. "IT WAS NOT A DANGEROUS CONDITION, SIMPLY THE BLADES OF THE SCISSORS REMAINED LOCKED IN THE OPEN POSITION, PHYSIOLOGICAL TISSUES (PERITONEUM) WERE CUT AND THE BLADES WERE NOT DAMAGED" ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 16MAR2022: ONLY ONE SCISSORS ARE INVOLVED IN THE ACCIDENT, BUT THE CUSTOMER ALSO WANTS TO RETURN THE REMAINING SCISSORS OF THE DEFECTIVE BATCH(3 STERILE SAMPLES). ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14607240 ↗
• MalfunctionJun 6, 2022Difficult to Open or Close; Material Deformation; Mechanical Jam; Difficult to Open or Close; Material Deformation; Mechanical Jam

  PROCEDURE PERFORMED: NA (STERILE UNIT RETURNED). EVENT DESCRIPTION: COMPLAINT 1 OF 4:(B)(6) [MFR #2027111-2022-00533], COMPLAINT 2 OF 4: (B)(6), COMPLAINT 3 OF 4: (B)(6), COMPLAINT 4 OF 4: (B)(6). WHILE THE SURGEON WAS TRYING TO CUT USING APPLIED MEDICAL SCISSORS, THE DEVICE BLOCKED THE JAWS. THE SCISSOR NO LONGER OPENED, LOCKING ALSO IN THE HANDLE. THE SURGEON ALSO HAD DIFFICULTY REMOVING THE DEVICE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 16MAR2022: YES, THE DOES NOT WORK UPON INITIAL USE JUST AFTER A FEW MINUTES OF USE THE SCISSORS DID NOT OPEN ANYMORE THE BLADES DID NOT OPEN/CLOSE FULLY AT THE BEGINNING THE SCISSORS WERE NOT USED TO CUT STAPLES/ LAPBAND/DENSE TISSUE 'IT WAS NOT A DANGEROUS CONDITION, SIMPLY THE BLADES OF THE SCISSORS REMAINED LOCKED IN THE OPEN POSITION, PHYSIOLOGICAL TISSUES (PERITONEUM) WERE CUT AND THE BLADES WERE NOT DAMAGED". ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 16MAR2022: ONLY ONE SCISSORS ARE INVOLVED IN THE ACCIDENT, BUT THE CUSTOMER ALSO WANTS TO RETURN THE REMAINING SCISSORS OF THE DEFECTIVE BATCH (3 STERILE SAMPLES). ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14607202 ↗
• MalfunctionJun 6, 2022Difficult to Open or Close; Material Deformation; Mechanical Jam; Difficult to Open or Close; Material Deformation; Mechanical Jam

  PROCEDURE PERFORMED: NA (STERILE UNIT RETURNED). EVENT DESCRIPTION: COMPLAINT 1 OF 4: 2022-000726 [MFR #2027111-2022-00533]. COMPLAINT 2 OF 4: 2022-001472. COMPLAINT 3 OF 4: 2022-001473. COMPLAINT 4 OF 4: 2022-001474. WHILE THE SURGEON WAS TRYING TO CUT USING APPLIED MEDICAL SCISSORS, THE DEVICE BLOCKED THE JAWS. THE SCISSOR NO LONGER OPENED, LOCKING ALSO IN THE HANDLE. THE SURGEON ALSO HAD DIFFICULTY REMOVING THE DEVICE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: YES, THE DOES NOT WORK UPON INITIAL USE JUST AFTER A FEW MINUTES OF USE THE SCISSORS DID NOT OPEN ANYMORE THE BLADES DID NOT OPEN/CLOSE FULLY AT THE BEGINNING. THE SCISSORS WERE NOT USED TO CUT STAPLES/ LAPBAND/DENSE TISSUE. IT WAS NOT A DANGEROUS CONDITION, SIMPLY THE BLADES OF THE SCISSORS REMAINED LOCKED IN THE OPEN POSITION, PHYSIOLOGICAL TISSUES (PERITONEUM) WERE CUT AND THE BLADES WERE NOT DAMAGED. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2022: ONLY ONE SCISSORS ARE INVOLVED IN THE ACCIDENT, BUT THE CUSTOMER ALSO WANTS TO RETURN THE REMAINING SCISSORS OF THE DEFECTIVE BATCH(3 STERILE SAMPLES). ADDITIONAL INFORMATION RECEI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14607139 ↗
• MalfunctionMay 23, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: TLH. EVENT DESCRIPTION: FACILITY: [USER FACILITY] HOSPITAL. SUBJECT OF COMPLAINT: THE BLADE OPENING WAS VERY POOR. THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. REPORT FROM THE SALES REP THE BLADE OPENING WAS VERY POOR DURING 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). COMPONENTS 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 14479515 ↗
• MalfunctionMay 11, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED: LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. EVENT DESCRIPTION: FACILITY: [USER FACILITY]. "SCISSORS INSERT TO 5MM TROCAR (LAGIS) BUT THE TIP OF SCISSORS CAN'T CLOSE. THIS DEVICE FUNCTION IS ABNORMAL. THE TROCAR CANNOT REMOVE FROM THIS PAIR OF SCISSORS DUE TO SCISSORS' FLAW. CLIENT RETURNS THE DEFECT DEVICE TOGETHER WITH LAGIS 5MM TROCAR. PLEASE CONSULT WITH ATTACHED PHOTOS. PATIENT SUFFERED MORE WOUNDS WHEN SURGEON REMOVE THIS DEVICE. THEY REPLACED WITH A NEW ONE TO COMPLETED THIS SURGERY. WE OFFER A CTR03 TO MAKE UP THE CUSTOMER LOSS OF [COMPETITOR] TROCAR." ADDITIONAL INFORMATION RECEIVED VIA EMAIL 28APR2022 FROM [DISTRIBUTOR]: THE DEVICE WAS FUNCTIONAL UPON INITIAL USE. THE BLADES DID NOT CLOSE FULLY WHEN THE SURGEON CUT UTERINE LIGAMENTS FOR SOME TIME. "THE WOUND MUST TO ENLARGE 10MM IN ORDER TO REMOVE THE SCISSORS." PATIENT IS CURRENTLY DOING WELL. THE CASE WAS COMPLETED WITH A NEW CB030. INTERVENTION: "THEY REPLACED WITH A NEW ONE TO COMPLETED THIS SURGERY." PATIENT STATUS: PATIENT IS CURRENTLY DOING WELL..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366201 ↗
• MalfunctionMay 5, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED. NA. (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [FACILITY] INCOMING INSPECTION PO# (B)(4). THIS IS A COMPLAINT FROM [FACILITY] 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 #1438415 (1 EA.). PATIENT STATUS: NA. (INCOMING INSPECTION). TYPE OF INTERVENTION: NA. (INCOMING INSPECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288201 ↗
• MalfunctionApr 12, 2022Difficult to Open or Close; Difficult to Open or Close

  PROCEDURE PERFORMED:GASTRIC BAND . EVENT DESCRIPTION: LES CISEAUX NE SE FERMENT PAS. [TRANSLATION] THE SCISSORS DON'T CLOSE. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 15-MAR-2022: THE SCISSORS WERE NOT USED BECAUSE THEY WERE DEFECTIVE UPON OPENING. THE SURGEON INTENDED TO CUT THE GASTRIC BAND AND GASTRIC BAND CATHETER TO REMOVE THEM. THE PROCEDURE WAS A GASTRIC BAND. THE DATE WAS (B)(6) 2022. THE PATIENT DID NOT SUFFER ANY INJURY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 12-APR-2022: THE SURGEON TOOK AN EB210 FROM ANOTHER KIT. THE CUSTOMER ONLY PURCHASES GK887 KITS. INTERVENTION: CHANGE TO EB210. PATIENT STATUS: THE PATIENT DID NOT SUFFER ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087687 ↗
• MalfunctionMar 31, 2022Arcing; Arcing

  PROCEDURE PERFORMED: INGUINAL HERNIA. EVENT DESCRIPTION: SCISSOR COAGULATED AT THE LEVEL OF GREEN COATING NOT AT THE LEVEL OF THE SCISSOR. THEY TOOK ANOTHER SCISSOR AND FINISHED THE PROCEDURE WITHOUT PROBLEM PATIENT OK!. [TRANSLATION]: I JUST RECEIVED A SCISSOR BACK THAT COAGULATES AT THE LEVEL OF THE GREEN COATING (WHERE THE LOGO OF THE COMPANY IS) AND NOT AT THE SCISSOR SECTION. THIS CAUSES DANGEROUS SITUATIONS. EPIX SCISSORS CB030 (LOT 1443223). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 21-MAR-2022: THE UNIT WAS PUT ASIDE, BUT TODAY THEY WERE NOT ABLE TO LOCATE IT TO BE RETURNED FOR THE INVESTIGATION. THE TERRITORY MANAGER IS TRYING TO LOCATE IT, ALTERNATIVELY THEY POTENTIALLY HAVE FOOTAGE OF THE INCIDENT. HE DESCRIBED IT AS COAGULATION OF CONNECTIVE TISSUE 5CM INTO THE ISOLATION OF THE SCISSORS. LUCKILY IT WAS ONLY CONNECTIVE TISSUE, BUT THEY WERE VERY WORRIED IN CASE IT WOULD HAPPEN IN ANOTHER PROCEDURE AND FOR EXAMPLE ACCIDENTLY PUNCTURE THE COLON WITHOUT NOTICING. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 25-MAR-2022: THE INCIDENT HAPPENED DURING AN INGUINAL HERNIA REPAIR. THE PATIENT WAS NOT HURT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13968303 ↗
• MalfunctionMar 30, 2022Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  PROCEDURE PERFORMED: LAPAROSCOPIC ENDOMETRIOSIS ERADICATION. EVENT DESCRIPTION: WHILE THE SURGEON WAS TRYING TO CUT USING APPLIED MEDICAL SCISSORS, THE DEVICE BLOCKED THE JAWS. THE SCISSOR NO LONGER OPENED, LOCKING ALSO IN THE HANDLE. THE SURGEON ALSO HAD DIFFICULTY REMOVING THE DEVICE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 16MAR22: YES, THE DOES NOT WORK UPON INITIAL USE JUST AFTER A FEW MINUTES OF USE THE SCISSORS DID NOT OPEN ANYMORE. THE BLADES DID NOT OPEN/CLOSE FULLY AT THE BEGINNING. THE SCISSORS WERE NOT USED TO CUT STAPLES/ LAPBAND/DENSE TISSUE. "IT WAS NOT A DANGEROUS CONDITION, SIMPLY THE BLADES OF THE SCISSORS REMAINED LOCKED IN THE OPEN POSITION, PHYSIOLOGICAL TISSUES (PERITONEUM) WERE CUT AND THE BLADES WERE NOT DAMAGED" ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 16MAR22: ONLY ONE SCISSORS ARE INVOLVED IN THE ACCIDENT, BUT THE CUSTOMER ALSO WANTS TO RETURN THE REMAINING SCISSORS OF THE DEFECTIVE BATCH(3 STERILE SAMPLES). INTERVENTION: NI. PATIENT STATUS: "OK".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955404 ↗
• MalfunctionMar 23, 2022Failure to Cut; Failure to Cut

  PROCEDURE PERFORMED: LAPRASCOPIC HERNIA. EVENT DESCRIPTION: THE DEVICE WAS BEING USED WHEN PERFORMING ALF DEACON - LAPRASCOPIC HERNIA. SCISSORS FAILED TO CUT TISSUE. IT DID NOT JAM, THE JAWS CLOSED BUT DID NOT CUT THE TISSUE. SURGEON THEN OPENED ANOTHER PAIR OF EPIX LAPRASCOPIC SCISSORS AND COMPLETED THE SURGERY WITH THOSE. THERE WERE NO CHANGES IN PATIENT HEALTH RESULTING FROM THE EVENT. DEVICE REPLACED WITH SAME MODEL SCISSORS AND SUCCESSFULLY COMPLETED SURGERY INTERVENTION: DEVICE REPLACED WITH SAME MODEL SCISSORS AND SUCCESSFULLY COMPLETED SURGERY. PATIENT STATUS: NO COMPLICATIONS AROSE FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865282 ↗