Kii Fios First Entry CFF33Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00607915119874), received between Mar 30, 2018 and Jun 17, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (54 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC RADICAL PROSTATECTOMY. EVENT DESCRIPTION: INFORMATION RECEIVED IN THE CUSTOMER COMPLAINT FORM: THE INCIDENT INVOLVED: THE DEPARTMENT REALIZED THAT A PIECE OF PLASTIC MISSING FROM THE TIP OF THE TROCAR WHEN THE PATIENT WAS DISCHARGED. CONSEQUENCES FOR THE PATIENT: THE PIECE OF PLASTIC WAS FOUND IN THE AND WAS REMOVED. THE SYSTEM HAS BEEN RETAINED. THIS IS AN ISOLATED INCIDENT. ADDITIONAL INFORMATION RECEIVED IN THE PCF: AT THE END OF THE INTERVENTION, THEY NOTICE THAT A LITTLE PIECE OF PLASTIC BROKE AT THE TIP AND THEY FIND IT IN THE ABDOMEN OF THE PATIENT. THEY REMOVE IT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 10JUN26: NO CONSEQUENCE FOR THE PATIENT. THE SURGEON FOUND AND RECOVERED THE PIECE LEFT IN THE PATIENT. IT HAPPENED AT THE END, WHEN THE TROCAR IS REMOVED. THE BREAK OCCURRED AT THE CANNULA TIP. THE BREAK CAUSED PARTICULATION AND ALL PIECES REMOVED FROM THE PATIENT. THE BREAK WAS IDENTIFIED DURING THE PATIENT¿S REMOVAL. TROCAR WAS INSERTED BY ROTATING ALTERNATELY CLOCKWISE AND COUNTERCLOCKWISE. NO DIFFICULTY DURING INSERTION AND THIS TROCAR WAS USED WITH A ROBOT. IT WAS USED WITH DA VINCI X ROBOT ASSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534387 ↗
• MalfunctionMay 14, 2026Material Fragmentation

  PROCEDURE PERFORMED: BSO. EVENT DESCRIPTION: ACCORDING TO THE SURGEON, A VERY SMALL PIECE FROM THE BEVELED EDGE OF THE GREEN SIZE 11 CANNULA FELL INSIDE THE PATIENT¿S BODY, BUT THEY WERE UNABLE TO RETRIEVE IT. THEY TRIED SEVERAL TIMES USING SUCTION IRRIGATION. INTERVENTION: THEY TRIED TO RETRIEVE THE PIECE SEVERAL TIMES USING SUCTION IRRIGATION. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167044 ↗
• MalfunctionMar 5, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON (B)(6) 26: AS THIS HAPPENED 2 MONTHS AGO AND NEITHER HCP THE APPLIED MEDICAL REP SPOKE TO WERE PRESENT DURING THE PROCEDURE, THERE ISN¿T AN OVERLY DETAILED DESCRIPTION OF WHAT HAPPENED. THE BEST WE CAN ASCERTAIN IS, THE SURGEON INSERTED THE SCOPE INTO THE OBTURATOR, THE TIP OF THE OBTURATOR GAVE WAY. THE TIP ENDED UP IN THE PATIENT AND WAS RETRIEVED IMMEDIATELY BY THE SURGEON; THE PATIENT WAS NOT AFFECTED. THE HOSPITAL HAS TAKEN THEIR STOCK OF CFF33 OUT OF CIRCULATION AND AWAIT INSTRUCTION ON HOW TO PROCEED. THE AFFECTED DEVICE IS TO BE COLLECTED FROM THEATRE, CONTACT EMAIL AND ADDRESS BELOW. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON (B)(6) 26: PROCEDURE WAS LAP CHOLE, HIGH BMI PATIENT. BESIDES THE SCOPE, NO OTHER INSTRUMENTS WERE USED AT THE TIME OF THE INCIDENT. IT WAS NOT A ROBOTIC SURGERY. ONE CANNULA WAS INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. PIECES FELL INTO THE PATIENT AND ALL WERE RETRIEVED. THE TROCAR WAS INSERTED WITH ROTATION. PATIENT WAS HIGH BMI, STAFF DON¿T RECALL ANYTHING OUT OF THE ORDINARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520697 ↗
• MalfunctionFeb 12, 2026Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: DISTAL END OF THE SLEEVE BALLOON BREAKS DURING OPERATION, SEARCH FOR 30 MINUTES, FOUND. INTERVENTION: USED ANOTHER TROCAR. PATIENT STATUS: NO PATIENT INJURY NOR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328919 ↗
• MalfunctionFeb 12, 2026Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: DURING A LAPAROSCOPIC APPENDECTOMY, AFTER INSERTING THE TROCAR INTO THE NAVEL, THE SURGEON DISCOVERED FRAGMENTS OF THIS MEDICAL DEVICE IN THE PERITONEAL CAVITY. THE FRAGMENTS WERE RETRIEVED AND DISCARDED. 27JAN26: MIR REQUESTED, ANSM REF NUMBER (B)(4). INTERVENTION: THE FRAGMENTS WERE RETRIEVED AND DISCARDED. PATIENT STATUS: THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328905 ↗
• MalfunctionJan 26, 2026Material Fragmentation

  EVENT DESCRIPTION: WHEN PLACING THE BAG THROUGH THE OBTURATOR TO COLLECT THE GALLBLADDER FROM THE ABDOMEN, THE TWO BOTTOM PIECES OF THE OBTURATOR CAME APART INSIDE THE ABDOMEN. THE DEVICE HAD TO BE CHANGED FOR ANOTHER IN ORDER TO CONTINUE THE SURGERY AND REMOVE THE BROKEN PIECES FROM THE OBTURATOR. NEAR MISS AS BROKEN PIECES WERE RETRIEVED FROM THE ABDOMEN WITH NO AFFECT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20JAN26: NO ADDITIONAL INFORMATION. INTERVENTION: REPLACED DAMAGED PORT (OBTURATOR) USED BAG TO REMOVE GALLBLADDER TO RETRIEVE THE BROKEN/DETACHED PARTS FROM THE ABDOMEN. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184073 ↗
• MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: [NAME REDACTED] WAS OPERATING WHEN A FRAGMENT OF THE 11MM KII FIOS TROCAR (CFF33) BROKE OFF AND FELL INTO THE PATIENT WHILST INSERTING A 5MM TROCAR THAT MADE CONTACT WITH THE 11MM TROCAR. THE 11MM CAMERA PORT WAS ANGLED TOWARDS THE 5MM PORT AND MADE CONTACT ONCE ENTERING THE ABDOMINAL CAVITY. THE FRAGMENT THAT HAD BROKE OFF WAS RETRIEVED. THE CUSTOMER HAS THE TROCAR IN POSSESSION AND WOULD LIKE A REPLACEMENT. INTERVENTION: THE FRAGMENT THAT HAD BROKE OFF WAS RETRIEVED. PATIENT STATUS: PATIENT UNAFFECTED BY EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771075 ↗
• MalfunctionDec 2, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: UNDER INSERTION, THE TIP OF THE OBTURATOR BROKE OFF INTO SEVERAL PIECES. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28NOV2025: THE END OF THE TROCAR FRAGMENTED/CRACKED IN SEVERAL PIECES DURING INSERTION. THE ABDOMEN WAS ALREADY ISUFFLATED WITH CO2 USING VERSES NEEDLE PRIOR TO THE TROCAR INSERTION. THERE HAD BEEN SOME FORCE INVOLVED IN GETTING IT THROUGH THE ABDOMEN, BUT ACCORDING TO THE SURGICAL NURSE, NOT ENOUGH FOR SOMETHING LIKE THIS TO HAPPEN. SHE DIDN'T SAY ANYTHING ABOUT THE SPECIFIC INSERTION METHOD FOR THE TROCAR. THEY HAD OPENED A SECOND TROCAR [THIS COMPLAINT] THAT THEY USED DURING THE PROCEDURE, BUT WHEN THEY APPLIED LIGHT PRESSURE ON THE END OF IT AFTER IT HAD BEEN REMOVED/AFTER THE OPERATION, IT ALSO FRAGMENTED INTO SEVERAL PIECES LIKE THE FIRST ONE (WHICH IS WHY A COMPLAINT HAS ALSO BEEN MADE ABOUT THIS TROCAR). NO PIECES FELL INTO THE PATIENT AND NO HARM WAS DONE AS A RESULT OF THE INCIDENT. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697978 ↗
• MalfunctionDec 2, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: UNDER INSERTION, THE TIP OF THE OBTURATOR BROKE OFF INTO SEVERAL PIECES. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2025: THE END OF THE TROCAR FRAGMENTED/CRACKED IN SEVERAL PIECES DURING INSERTION. THE ABDOMEN WAS ALREADY SUFFLATED WITH CO2 USING VERSES NEEDLE PRIOR TO THE TROCAR INSERTION. THERE HAD BEEN SOME FORCE INVOLVED IN GETTING IT THROUGH THE ABDOMEN, BUT ACCORDING TO THE SURGICAL NURSE, NOT ENOUGH FOR SOMETHING LIKE THIS TO HAPPEN. SHE DIDN'T SAY ANYTHING ABOUT THE SPECIFIC INSERTION METHOD FOR THE TROCAR. THEY HAD OPENED A SECOND TROCAR THAT THEY USED DURING THE PROCEDURE, BUT WHEN THEY APPLIED LIGHT PRESSURE ON THE END OF IT AFTER IT HAD BEEN REMOVED/AFTER THE OPERATION, IT ALSO FRAGMENTED INTO SEVERAL PIECES LIKE THE FIRST ONE (WHICH IS WHY A COMPLAINT HAS ALSO BEEN MADE ABOUT THIS TROCAR). NO PIECES FELL INTO THE PATIENT AND NO HARM WAS DONE AS A RESULT OF THE INCIDENT. [INTERVENTION UPDATED (B)(6) 2025]. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE ON (B)(6) 2025: THE CORRECT NUMBER IS TEN TROCARS IN TOTAL (TWO NON-STERILE USED DURING THE INCIDENT), AND EIGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697902 ↗
• MalfunctionOct 31, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ROBOTIC PROCEDURE (LAPAROSCOPIC NEPHRECTOMY). EVENT DESCRIPTION: [TRANSLATION] DURING THE ROBOTIC PROCEDURE (LAPAROSCOPIC NEPHRECTOMY), A PIECE OF TROCAR WAS DISCOVERED WHEN CLOSING THE INCISION IN THE LEFT ILIAC FOSSA. AFTER INSPECTING THE TROCAR DURING ITS REMOVAL, THE SURGEON REALIZED THAT THE DISTAL TIP WAS BROKEN IN SEVERAL PLACES. THREE PIECES WERE EXTRACTED FROM THE PATIENT. PROCEDURE EXTENDED TO CHECK FOR OTHER FRAGMENTS IN THE PATIENT'S ABDOMEN. ACTIONS TAKEN BY THE HEALTHCARE FACILITY TO TREAT THE PATIENT: PATIENT NOTIFIED. A CT SCAN WAS PERFORMED TO CHECK AGAIN FOR TROCAR FRAGMENTS. IMMEDIATE WITHDRAWAL OF THE BATCHES IN QUESTION. INTERVENTION: PROCEDURE EXTENDED TO CHECK FOR OTHER FRAGMENTS IN THE PATIENT'S ABDOMEN. A CT SCAN WAS PERFORMED TO CHECK AGAIN FOR TROCAR FRAGMENTS. PATIENT STATUS: PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442546 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: I HAVE RECEIVED A REPORT ABOUT BROKEN TROCAR. THIS TIME FROM OUS - [ACCOUNT NAME]: ID: (B)(6). LOT NUMBER: 1554010. CFF33 KII FOS FIRST ENTRY, ADVANCED FIXATION. THE NURSE REPORTING THE INCIDENCE TO ME BY PHONE TODAY WAS NOT IN PLACE WHEN THE INCIDENCE OCCURRED. SHE RECEIVED THE INFORMATION THE 18TH OF SEPTEMBER. SHE HAS NOT HAD THE OPPORTUNITY TO ASK THE PERSONS IN THE OPERATING ROOM ABOUT WHAT HAPPENED. SHE HAS BEEN IN VACATION. AS FAR AS SHE KNOWS, THE PATIENT WAS NOT HARMED BY THE INCIDENCE. THEY PICKED UP THE LOOSE BIT OF PLASTIC. SHE WILL TRY TO COLLECT INFORMATION FROM HER COLLEAGUES MONDAY NEXT WEEK. I WILL FOLLOW HER UP WITH ANSWERS FOR QUESTIONS THAT I HAVE ALREADY WRITTEN TO HER IN THE EMAIL. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 06OCT2025: THEY USED CLAMPS TO LIFT THE ABDOMINAL WALL WHEN INSERTING VERRES NEEDLE. THE CLAMPS WERE STILL THERE WHEN INSERTING THE TROCAR. HE SAID THAT IT MIGHT BE THAT THE TROCAR WAS IN CONFLICT WITH THE CLAMP ON ITS WAY INSIDE THE ABDOMEN. ANYWAY, THEY SAW THE SMALL PIECE OF PLASTIC INSIDE THE ABDOMEN WHEN THE SCOPE /CAMERA WAS INSERT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303424 ↗
• MalfunctionOct 15, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC GYN.SURGERY EVENT DESCRIPTION: UMBILICUS - FIRST ENTRY, FIRST TROCAR INSERTED. AFTER USE OF VERRES NEEDLE CFF 33, KII FIOS FIRST ENTRY LOT NR, 1554010 SO FAR, THIS IS WHAT I KNOW BY EMAIL. I WILL CONTACT THE HOSPITAL TOMORROW, ABOUT MORE INFORMATION. LIKE WHAT KIND OF PROCEDURE AND HOW IT HAPPENED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA PCF ON 30SEP2025: THE INCIDENCE OCCURRED WHEN INSERTING THE TROCAR IN UMBILICUS. THEY USED VERRES NEEDLE TO INSUFFLATE THE ABDOMEN BEFORE INSERTING AND THE TIP BROKE WHEN INSERTING. THE INCIDENCE WAS REPORTED AS AN IRREGULARITY ACCIDENT AT THE DEPARTMENT. THE NURSE THAT RECEIVED THE INFORMATION WAS NOT IN PLACE AND THE INCIDENCE WAS REPORTED 18/9 WITH NO FURTHER EXPLANATION THAN I HAVE EXPLAINED. THE EVENT IS DESCRIBED AS GOOD AS POSSIBLE. THIS INCIDENT HAS HAPPENED EARLIER THIS YEAR ALSO, AND IT MIGHT BE THAT THERE ARE SURGEONS IN THIS HUGE DEPARTMENT THAT HAVE TO BE TAUGHT OR REMINDED HOW TO INSERT APPLIED KII FIOS FIRST ENTRY TROCAR WITH SEPARATING TIP IN THE RIGHT MANNER. I WILL TAKE CARE OF THIS! THEY PICKED SMALL PIECES OF THE TROCAR FROM INSIDE OF THE ABDOMEN AND THEN CHANGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280062 ↗
• MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE VIA PHONE ON 21AUG2025: WHILE TRYING TO ENTER THE ABDOMEN, THE TIP OF THE TROCAR BROKE. IT LOOKS LIKE THEY MELTED IT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 27AUG2025: THE ONLY ADDITIONAL INFORMATION I WAS ABLE TO GET WAS THAT THERE WAS NO HARM TO THE PATIENT AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 02SEP2025: THE BEND/BREAK CAUSED PARTICULATION. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE TROCAR WAS INSERTED WITH ROTATION. THERE WAS DIFFICULTY DURING INSERTION, THERE WAS RESISTANCE. THIS TROCAR WAS NOT USED WITH A ROBOT. FOUND THE LOT#1553358 INTERVENTION: SURGEON DID WOUND EXPLORATION AND ¿LOOKED WITH LAPAROSCOPIC CAMERA THROUGHOUT ENTIRE ABDOMEN AND DID NOT SEE A PIECE OF PLASTIC.¿ KUB WAS COMPLETED AND READ CLEAR BY RADIOLOGY. WOUND WAS CLOSED. PATIENT STATUS: NO PATIENT INJURY INDICATED. PATIENT WENT HOME THE NEXT DAY WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022534 ↗
• MalfunctionMay 5, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACIC SURGERY - VATS MEDUASTINAL MASS EXCISION. EVENT DESCRIPTION: HAPPENED DURING THE SURGERY (THE TEAM CAN'T IDENTIFY THE EXACT MOMENT) IN THE INSTRUMENTATION PORT, USING OUR GRASPER C4130 AND [BRAND REDACTED] MARYLAND ALTERNATED. THEY JUST REALIZED THERE WAS A TROCAR FRAGMENT AND THEN IT WAS TOTALLY BROKEN, SEPARATED IN TWO PARTS. WHEN REMOVING THE TROCAR, THE PARTS WERE SEPARATED IN THE BALLOON AREA. THE TROCAR WAS PLACED BETWEEN RIBS AND THE PATIENT WAS STABLE WITH NO VISIBLE THORACIC CONTRACTIONS. NO IMPACT IN THE PATIENT STATUS. THE TROCAR AND FRAGMENTS WERE REMOVED AND PLACED A NEW TROCAR TO PROCEED WITH THE SURGERY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28APR25: THE TROCAR WAS INSERTED WITH ROTATION ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTION WITH NO DIFFICULTY DURING INSERTION. ROBOT WAS NOT USED. THEY CAN´T IDENTIFY THE EXACT MOMENT OF THE INCIDENT. THEY JUST REALIZED THERE WAS A FRAGMENT. IN THIS PORT IT WAS ONLY USED AN ATRAUMATIC GRASPER (C4130) AND [BRAND REDACTED] MARYLAND, ALTERNATED (BOTH 5MM). INTERVENTION: THE TROCAR AND FRAGMENTS WERE REMOVED AND PLACED A NEW TROCAR TO PROCEED WITH T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964724 ↗
• MalfunctionApr 21, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: [TRANSLATION] I AM WRITING TO REPORT AN ADVERSE EVENT THAT OCCURRED WITH A TROCART KII F I O S FIXATION BALLONNET INSUFFLATION 11MM*100MM, REFERENCE CFF33, LOT NUMBER 1544901 : TROCAR VALVE MISMATCHED AND FALLS INTO PATIENT'S ABDOMEN ON INSERTION. BROKEN TROCAR DISTAL TIP IN PATIENT. PROBLEM VISUALIZED ON TROCAR EXTRACTION. FOR YOUR INFORMATION, THE DEVICE IS AVAILABLE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED. THE DATE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877986 ↗
• MalfunctionApr 3, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  PROCEDURE PERFORMED: LAP NISSEN. EVENT DESCRIPTION: DR WAS ABOUT TO START HIS CASE WHICH IS A LAP NISSEN AND WANTED TO ENTER THE PATIENT VIA THE ENTRY TROCAR WHEN HE WAS MET WITH RESISTANCE UPON PLACING THE TROCAR ON THE PATIENT. HE THEN INSPECTED THE TIP AND FOUND THAT IT WAS BENT BACK AND WAS NOT ABLE TO ENTER WITH THE INTRODUCER AND WAS ALSO UNABLE TO REMOVE THE INTRODUCER SO A NEW TROCAR WAS OPENED AND THE PROCEDURE CONTINUED. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 04FEB25: NO IMAGES ARE AVAILABLE AS THE TROCAR WAS IMMEDIATELY DOUBLE RED BAGGED. UNKNOWN ON HOW THE TROCAR WAS INSERTED. CONFIRMED IF WAS THE OBTURATOR THAT BENT AND UNABLE TO BE PULLED OUT FROM THE SLEEVE. INTERVENTION: A SECOND DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH THE SECOND DEVICE. PATIENT STATUS: PATIENT IS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767494 ↗
• MalfunctionFeb 25, 2025Fracture; Fracture

  PROCEDURE PERFORMED: ANTERIOR MEDIASTINAL BIOPSY - THORACIC SURGERY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) (MFR REPORT NUMBER 2027111-2025-00384). COMPLAINT 2 OF 2: (B)(4) (MFR REPORT NUMBER 2027111-2025-00385). THE TROCARS WERE INSERTED AND THE BALLOON INFLATED AS USUAL. NO SPECIFIC ACTION IDENTIFIED AS THE POSSIBLE CAUSE TO THE INCIDENT. IT WAS USED 2 CFF33 (VIDEOSCOPE AND INSTRUMENT) AND 1 CFF03 (INSTRUMENT) FOR THIS PROCEDURE. DURING THE PROCEDURE THE SURGEON REALIZED THERE WAS A PLASTIC PIECE INSIDE THE PATIENT. AFTER AN INSPECTION, THEY CONCLUDED IT WAS A PLASTIC FRAGMENT FROM THE TIP OF A CFF33. IT WAS REMOVED AND THEY CONTINUED WITH THE SURGERY. AT THE END OF THE SURGERY, THEY REALIZED BOTH CFF33 WERE CRACKED LONGITUDINALLY, NOT ONLY THE BROKEN ONE. CFF03 WAS OK. ACCORDING TO THE SURGEON, THE PATIENT WAS VERY OBESE AND HAD A LOT OF MUSCULAR CONTRACTIONS DURING THE PROCEDURE. THEY USED THE TROCARS UNTIL THE END OF THE SURGERY. NO ADDITIONAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 21FEB25: THE DEVICES [CFF33] HAS THE SAME LOT NUMBER. THE TROCAR WAS NOT USED WITH A ROBOT. THEY CAN'T IDENTIFY THE TIME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464873 ↗
• MalfunctionFeb 25, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  PROCEDURE PERFORMED: ANTERIOR MEDIASTINAL BIOPSY: THORACIC SURGERY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4). COMPLAINT 2 OF 2: (B)(4). THE TROCARS WERE INSERTED AND THE BALLOON INFLATED AS USUAL. NO SPECIFIC ACTION IDENTIFIED AS THE POSSIBLE CAUSE TO THE INCIDENT. IT WAS USED 2 CFF33 (VIDEOSCOPE AND INSTRUMENT) AND 1 CFF03 (INSTRUMENT) FOR THIS PROCEDURE. DURING THE PROCEDURE THE SURGEON REALIZED THERE WAS A PLASTIC PIECE INSIDE THE PATIENT. AFTER AN INSPECTION, THEY CONCLUDED IT WAS A PLASTIC FRAGMENT FROM THE TIP OF A CFF33. IT WAS REMOVED AND THEY CONTINUED WITH THE SURGERY. AT THE END OF THE SURGERY, THEY REALIZED BOTH CFF33 WERE CRACKED LONGITUDINALLY, NOT ONLY THE BROKEN ONE. CFF03 WAS OK. ACCORDING TO THE SURGEON, THE PATIENT WAS VERY OBESE AND HAD A LOT OF MUSCULAR CONTRACTIONS DURING THE PROCEDURE. THEY USED THE TROCARS UNTIL THE END OF THE SURGERY. NO ADDITIONAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 21FEB2025: THE TROCAR WAS INSERTED WITH ROTATION AS THEY USUALLY DO WITH NO DIFFICULTY DURING INSERTION. THE BREAK DID NOT CAUSE PARTICULATION ONLY IN ONE PIECE AND THE PIECE WAS RETRIEVED FROM THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464855 ↗
• MalfunctionJan 3, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ENDOSCOPIC MITREAL VALVE. EVENT DESCRIPTION: BEING USED AS A PORT FOR THE SCOPE. ONCE THE PROCEDURE HAD FINISHED THE SURGEON AND REGISTRAR NOTICED THAT THE PORT WAS BROKEN AT THE TIP OF THE CANNULA. THE ONLY INSTRUMENT USED IN THE PORT THROUGHOUT WAS THE SCOPE. THE STAFF DID NOT NOTICE THE BROKEN TROCAR TILL THE PORT HAD BEEN REMOVED. THEY HAVE CONFIRMED THAT THEY DID NOT MANAGE TO FIND THE FRAGMENTED PIECES IN THE PATIENT, BUT IT WAS NOT A CONCERN TO THE PATIENTS OUTCOME OR RECOVERY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16DEC24: THE TROCAR WAS INSERTED - 10 TO 2 TWISTING MOTION AND NO DIFFICULTY DURING INSERTION. THERE WAS NO DIFFICULTY DURING INSERTION. THE PATIENT DID NOT HAVE PREVIOUS SURGERY AT THE SITE. THE BREAK DID CAUSE PARTICULATION. THE TROCAR WAS NOT USED WITH A ROBOT. TYPE OF INTERVENTION: NO DEVICE REPLACEMENT AS IT WAS NOT NOTICED TILL THE END OF THE CASE. PATIENT STATUS: NO INJURY OR DEATH TO PATIENT. PATIENT SAFE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074399 ↗
• MalfunctionNov 26, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: SURGEON IS NOT SURE WHEN THE EVENT HAD BEEN DONE BUT HE SAW A PARTICLE OF CANNULA IN THE PATIENT STOMACH THEN CHECK THE EDGE OF TROCARS BY CAMERA AND FOUND THE BROKEN TROCAR. TYPE OF INTERVENTION: CHANGING THE TROCAR. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789731 ↗
• MalfunctionNov 25, 2024Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: PLACEMENT OF THE TROCARS WAS VERY DIFFICULT. WHEN REMOVING THEY NOTICED THE TIP WAS "CROOKED". AFTERWARDS THEY CLEANSED THE TROCAR (BEFORE PUTTING IT ON THE DESK), HERE THE TIP BROKE. NO CLINICAL IMPACT TO PATIENT. INTERVENTION: REPLACEMENT. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774193 ↗
• MalfunctionNov 21, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ENDOSCOPIC CARDIO-THORACIC PROCEDURE. EVENT DESCRIPTION: WHILE DOING THE SURGERY, THE REGISTRAR NOTICED A SMALL BROKEN PIECE OF THE 11 MM PORT INSIDE THE CHEST AND THE SURGEON REMOVED THE PIECE. TOWARDS THE END OF THE PROCEDURE, THEY FOUND ANOTHER BROKEN PIECE WHICH THEY HAVE ALSO REMOVED. SURGEON CHECKED INSIDE THE CHEST FOR ANY LEFT-OVER PIECES. WHEN THE BROKEN 11MM PORT WAS OUT, I CHECKED THE BROKEN PIECES WITH THE PORT AND SURGEON DID AS WELL. SURGEON CONFIRMED THAT HE IS HAPPY WITH THE COLLECTED BROKEN PIECES. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 08NOV24: PROCEDURE TO BE CONFIRMED EARLY NEXT WEEK. THE TROCAR WAS INSERTED IN A 10 TO 2 TWISTING MOTION AND NO DIFFICULTY DURING INSERTION. THE PATIENT WAS NOT CONSIDERED BARIATRIC WITH NO PREVIOUS SURGERIES AROUND THE SAME PLACEMENT. AT THE TIME THEY NOTICED THE BROKEN FRAGMENTS OF PLASTIC, NO INSTRUMENTS WAS IN THE CANNULA. THE TROCAR WAS NOT USED WITH A ROBOT. TYPE OF INTERVENTION: IT WAS USED THROUGHOUT THE PROCEDURE AND NO RESOLUTION WAS TAKEN TO REPLACE THE DEVICE DURING THE PROCEDURE. PATIENT STATUS: NO INJURY/DEATH TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751217 ↗
• MalfunctionOct 21, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: FUNDOPLICATION. EVENT DESCRIPTION: AFTER INCISION, THE TROCAR WAS PLACED IN THE ABDOMINAL WALL WITH LIGHT PRESSURE AND TURNING AS RECOMMENDED. AT THE END OF THE SURGERY BY REMOVING THE TROCARS, THE SURGEON DETECTED THAT THE TROCAR WAS BROKEN. THE MISSING PART WAS IMMEDIATELY SEARCHED FOR, BUT WITHOUT SUCCESS. IT IS STILL IN THE ABDOMINAL CAVITY. SO FAR, NO INDICATORS FOR INJURY, NO SYMPTOMS UNTIL TODAY. ADDITIONAL INFORMATION WAS RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18OCT24: IT WAS CONFIRMED IT WAS CANNULA THAT BROKE OFF. ADDITIONAL INFORMATION WAS RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18OCT24: CONFIRMED IT WAS THE TIP OF THE CANNULA THAT BROKE. IT WAS NOT USED WITH A ROBOT. THERE WERE NO INSTRUMENTS INSIDE OF THE CANNULA AT THE TIME OF INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 30DEC24: THE TM HAD BEEN IN CONTACT WITH THE LEADING NURSE BEFORE CHRISTMAS REGARDING PATIENT STATUS. THEY INDICATED THE PATIENT DID NOT SHOW UP AGAIN AND THEY DID NOT RECEIVE COMMUNICATION FROM AFTER THE TREATMENT POSITIONS I.E. FAMILY DOCTOR. THEY ASSUMED EVERYTHING IS ALRIGHT. PATIENT STAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496297 ↗
• MalfunctionSep 30, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY EVENT DESCRIPTION: TROCAR BROKE DURING INSERTION UNDER VISION, A PIECE BROKE OFF BUT WAS RETRIEVED. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL DISTRIBUTOR REPRESENTATIVE VIA EMAIL ON 30SEP24: THE BREAK AS AT THE TIP. THERE WAS NO DIFFICULTY DURING INSERTION, IT WAS ROTATED ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTION DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. LAPAROSCOPE WAS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT. TYPE OF INTERVENTION: RETRIEVED THE PIECE THAT BROKE OFF WITH A LAPAROSCOPIC GRASPER PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338178 ↗
• MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: BLADDER NECK DISSECTION DURING LAPAROSCOPIC RADICAL PROSTECTOMY. EVENT DESCRIPTION: DURING THE DISSECTION OF THE BLADDER NECK, THE TIP OF THE TROCAR FRAGMENTED AND THESE FRAGMENTS HAD TO BE LOCATED AND REMOVED. CLINICAL IMPACT TO THE PATIENT: NONE, IT WAS VERIFIED THAT THE FRAGMENTS REMOVED IN THEIR ENTIRETY CORRESPONDED TO THOSE DETACHED FROM THE TIP OF THE TROCAR. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 20JUN24: THE BEND/BREAK WAS IDENTIFIES DURING USE. THE TROCAR ROTATE IN ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTION DURING INSERTION AND THERE WAS NO DIFFICULTY DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. IT IS CONFIRMED IT WAS THE CANULA TIP THAT FRAGMENTED. GRASPER WAS USED INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. TYPE OF INTERVENTION: THE AFFECTED TROCAR IS REMOVED AND REPLACED WITH A NEW ONE PATIENT STATUS: FAVORABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580357 ↗