Kii Fios First Entry CTF73Recalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 00607915123703), received between Jan 26, 2016 and Sep 11, 2026 — classified as 5 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (69 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741735 ↗
• MalfunctionMar 11, 2026Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: THE TIP HAS BROKEN OFF DURING INSERTION. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570013 ↗
• MalfunctionMar 5, 2026Material Fragmentation

  PROCEDURE PERFORMED: LAP UNILATERAL SALPINGOOPHERCTOMY AND OMENTBIOPSY. EVENT DESCRIPTION: INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAIL, ON 17-FEB-26: NEW SIMILAR INCIDENT ON (B)(6). TODAY THE TIP OF TROCAR BROKE. [NAME REDACTED] HAS TAKEN THIS BOX OUT OF STORAGE AS SHE IS ¿CERTAIN¿ THAT THE PREVIOUS TROCAR CAME FROM THE SAME BOX. SHE WILL RETURN THE TROCAR FROM TODAYS EVENT. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE, VIA EMAILS, ON 20-FEB-26: WE ASKED THE CUSTOMER TO OPEN ONE STERILE TROCAR THAT HAVEN'T BEEN USED AND IT WILL BE RETURNING AS WELL; I SENT SOME PICTURES EARLIER TODAY. WE WILL OF COURSE SEND THEM A NEW ONE FOR THIS. NO PATIENT INJURY, PLASTICS WERE FOUND PREOPERATIVE, AND TO THEIR KNOWLEDGE NO PIECES LEFT IN THE ABDOMEN. PATIENT STATUS IS WELL. THE PLASTIC WAS DISCOVERED AND REMOVED. PROCEDURE WAS LAP UNILATERAL SALPINGOOPHERCTOMY AND OMENTBIOPSY. THE BREAK WAS IDENTIFIED AFTER USE, DURING INSPECTION. ALL PIECES WERE RETRIEVED FROM CUSTOMER. THE TROCAR WAS NOT USED WITH A ROBOT. EXPECTED PRODUCTS RETURNING: 1 UNIT USED IN THE SURGERY (EVENT UNIT); 1 UNIT NOT USED IN THE SURGERY BUT NON-STERILE; UNKNOWN QUANTITY OF STE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524582 ↗
• MalfunctionFeb 18, 2026Fracture

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: INFORMATION RECEIVED BY CUSTOMER, VIA EMAIL, ON 11FEB26: YESTERDAY ONE OF YOUR PRODUCTS, ENDOPORT 12MM KII FIOS 12X100 CTF73, WAS USED ON AN OPERATION AND WITHOUT ANYONE NOTICING FROM THE BEGINNING, THE TOP OF THE TROAKER BROKE. (SEE PICTURE) THE DEVIATION STATES THE FOLLOWING: "A LAPAROSCOPIC OPERATION IS PERFORMED. A KII PORT (12X100) IS SET IN CONNECTION WITH THE START OF THE OPERATION. AT THE END OF THE OPERATION, WHEN THE SPECIMEN IS TO BE REMOVED, THE OPERATOR NOTICES A CALLUS STUCK IN THE FASCIA. THE OPERATOR REMOVES THE TIP OF THE PLASTIC TROAKER (KII PORT) FROM THE FASCIA THAT HAS BROKEN IN CONNECTION WITH THE KII GATE WAS SET. PHOTO-DOCUMENTING THE BROKEN KII GATE." NEITHER THE PORT NOR THE PACKAGING HAS BEEN SAVED AND THEREFORE IT CANNOT BE TRACED TO ANY PARTICULAR BATCH, WHICH IS A SHAME. [CASE CONSIDERED NPR] INTERVENTION: THE OPERATOR REMOVES THE TIP OF THE PLASTIC TROAKER (KII PORT) FROM THE FASCIA THAT HAS BROKEN IN CONNECTION WITH THE KII GATE WAS SET. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384381 ↗
• MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC COLON SURGERY. EVENT DESCRIPTION: THE TROCAR WAS USED AS A CAMERA TROCAR IN COMBINATION WITH A 10MM LAPAROSCOPE OF COMPANY [NAME]. THE SURGEON IS A LONG TIME CUSTOMER AND USER OF OUR TROCARS. DURING THE LAPAROSCOPIC INTERVENTION THE SURGEON FOUND AN INNER PART OF THE TROCARS VALVE (THE TRANSPARENT CENTERING PIECE) IN THE ABDOMEN BY CHANCE. HE WAS ABLE TO RECOVER AND TO EXTRACT IT OUT OF THE ABDOMEN. THEY THAN REPLACED THE TROCAR AND CONSERVED THE DAMAGED TROCAR IN A CLOSED BAG. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18DEC2025: THE PRODUCT IS CONSERVED AT THE CUSTOMER SITE AND CAN BE COLLECTED AND SENT BACK TO AMERSFOORT. LOT NUMBER STILLS UNKNOWN AS IT WAS NOT DOCUMENTED AND THE PACKAGING WAS THROWN AWAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO INTERNAL SEAL COMPONENTS WERE REMOVED NOR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. THE TROCAR WAS USED AS A CAMERA TROCAR. THE CAMERA IS A 10MM [BRAND NAME] LAPAROSCOPE. BESIDES THAT REUSABLE INSTRUMENTS LIKE GRASPERS, SCISSORS AND SUCTION-IRRIGATION WAS USED. ALSO AN ENERGY DEVICE WAS INVOLVED - AS FAR AS I KNOW THEY ONLY HAVE [COMPETITOR ENERGY DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917916 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: I RECEIVED AN EMAIL FROM THE PHARMACIST TODAY, REGARDING AN INCIDENT OCCURRED WITH ONE OF OUR KII FIOS TROCAR CTF73. ACCORDING TO THE INCIDENT REPORT: "THE TROCAR LOST A PIECE OF ITS INTERNAL SEAL DURING THE EXTRACTION OF A PREFORMED SAUSAGE." "AS A RESULT, THE COMPRESS FELL BACK INTO THE PATIENT, ALONG WITH THE INFAMOUS PIECE OF SEAL. IMMEDIATE MEASURES: COMPRESS AND SEAL RECOVERED AND EXTRACTED FROM THE PATIENT; REMOVAL OF THE DAMAGED TROCAR AND INSERTION OF A NEW ONE." INTERVENTION: THE SURGEON TOOK OUT THE COMPRESS AND THE PIECE OF VALVE OF THE TROCAR OUT OF THE PATIENT BODY. THE SURGEON TOOK A NEW TROCAR TO CARRY ON THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652529 ↗
• MalfunctionAug 27, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: DURING PROCEDURE TROCAR WAS INSERTED IN THE PATIENT AND BEING USED FOR LAPAROSCOPIC SURGERY. A PIECE OF THE TROCAR THAT WAS INSIDE OF THE PATIENT BROKE OFF WHILE IN USE. THE TROCAR WAS REMOVED FROM THE PATIENT AND A REPLACEMENT WAS INSERTED. ADDITIONAL INFORMATION PROVIDED BY HOSPITAL REPRESENTATIVE VIA EMAIL ON 21AUG2025: THE PART THAT BROKEN WAS THE VERY TIP OF THE TROCAR THAT WAS INSIDE THE PATIENT. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905038 ↗
• MalfunctionJun 25, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP BSO AND CYSTECTOMY. EVENT DESCRIPTION: SCRUB NURSE OPENED TROCAR AND AS WAS PUTTING OBTURATOR INTO CANNULA PART OF THE SIDE TAB SNAPPED OFF. THE TROCAR HAD NOT BEEN NEAR THE PATIENT BEFOREHAND. NO PART OF THE TROCAR WAS NEAR THE PATIENT. PATIENT IS WELL. ONE OF THE SIDE TABS SNAPPED OFF DURING PREPARATION BY THE SCRUB NURSE. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16JUN25: TM CONFIRMED MODEL NUMBER CTF AND LOT NUMBER IS UNK. THE SCRUB NURSE WAS PUTTING THE OBTURATOR INTO THE CANNULA AND AS DOING SO, SHE WAS PINCHING THE TABS YES. INTERVENTION: ANOTHER TROCAR WAS OPENED AND USED FINE. PATIENT STATUS: NO PATIENT STATUS PROVIDED, EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332858 ↗
• MalfunctionJun 5, 2025Fracture; Fracture

  PROCEDURE PERFORMED: HEART PROCEDURE. EVENT DESCRIPTION: CRACKED TROCAR. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 16MAY2025 VIA EMAIL: DATE OF OCCURRENCE: (B)(6) 2025. PROCEDURE: HEART PROCEDURE. PATIENT STATUS: GOOD. ISSUE DESCRIPTION: CRACK WAS AT THE TIP OF THE SLEEVE. PRODUCT RETURN: PRODUCT IS AVAILABLE FOR RETURN. REQUESTED ACTION: CREDIT REQUESTED. ADDITIONAL INFO: A MORE DETAILED DESCRIPTION HAS BEEN REQUESTED FROM THE CIRCULATING NURSE; AWAITING RESPONSE. PATIENT STATUS: GOOD. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154038 ↗
• MalfunctionMay 9, 2025Fracture; Fracture

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: I WOULD LIKE TO RAISE AN ISSUE WITH ONE OF YOUR PORTS THAT YOU SUPPLY, CTF73, LOT NUMBER 1541793, THAT UNFORTUNATELY SNAPPED DURING A PROCEDURE. I WAS WONDERING IF YOU HAD ANY OTHER ISSUES WITH THIS PRODUCT PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996827 ↗
• MalfunctionMay 5, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAVH (EVENT OCCURRED BEFORE USE). EVENT DESCRIPTION: THE TROCAR WAS OPENED TO THE STERILE FIELD. AS THE OBTURATOR WAS PLACED INTO THE CANNULA, A PLASTIC CLIP ON THE SIDE OF THE SEAL DETACHED. THIS IS ONE OF TWO CLIPS THAT LOCK THE SEAL HOUSING IN PLACE ON THE CANNULA. THE TROCAR WAS OPENED IN A NORMAL MANNER. IT WAS NOT "FLIPPED" ONTO THE TABLE. NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. THE UNIT WAS NEVER PASSED TO THE SURGEON FOR USE. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 02MAY2025: THE COLOR OF THE PIECE WAS CLEAR. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. THE ENTIRE SEAL HOUSING AND THE CAP DID NOT DETACH. THE TABS WERE NOT BEING PINCHED AT THE TIME OF BREAKAGE. I WAS THERE WHEN IT WAS OPENED TO THE BACK TABLE. THE TECH TOOK THE TROCAR, AND WHEN SHE WENT TO ASSEMBLE IT (PUT THE OBTURATOR IN THE CANULA) A CLEAR PIECE OF PLASTIC FELL OFF OF THE CANULA. UPON INSPECTION IT WAS ONE OF THE CLIPS THAT CLIP THE CANNULA ONTO THE SEAL HOUSING. THE BROKEN PIECE AND THE TROCAR HAVE BEEN SHIPPED BACK TO YOU. INTERVENTION: OPENED ANOTHER CTF73 AND CONTINUED THE CASE. PATIENT STATUS: N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961898 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  PROCEDURE PERFORMED: LOBECTOMY. EVENT DESCRIPTION: TROCAR USED IN A THORACIC SURGERY (LOBECTOMY) FOR THE SCOPE ACCESS (ONLY TROCAR USED. ALSO USING ALEXIS FOR INSTRUMENTS ACCESS). TROCAR WAS PLACED WITH ROTATION, AS USUAL, IN A INTERCOSTAL SPACE. THE EVENT OCCURRED IN THE MIDDLE OF THE SURGERY AFTER INSERTING THE SCOPE (REMOVED TO CLEAN THE SCOPE) AND START MANIPULATING IT. THE TROCAR WAS USED FOR SCOPE ACCESS AND DURING THE SURGERY, AFTER THE SCOPE INSERTION AND SOME MANIPULATION, THE TEAM HEARD A CRACKING SOUND AND REALIZED THE TROCAR BROKE IN THE MIDDLE OF THE CANULA. NO FRAGMENTS IDENTIFIED. NO IMPACT IN THE PATIENT STATUS. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20MAR2025: THERE WAS DIFFICULTY DURING INSERTION AND WAS NOT USED WITH A ROBOT. INTERVENTION: THE SURGEON REMOVED THE TROCAR AND PLACED A NEW ONE. PATIENT STATUS: PATIENT IS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713299 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP SIGMARECTION. EVENT DESCRIPTION: INLAY (TRANSPARENT) SLIPPED OUT OF THE TROCAR. AFTER REMOVING A SWAB TWICE, THE INLAY (UNDAMAGED) WAS IN THE ABDOMINAL CAVITY, AFTER AN INSTRUMENT WAS INSERTED. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 05MAR25: THERE ARE NO PATIENT ISSUE AND THE COMPONENT DID NOT APPEAR TO BE TORN OFF. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27MAR25: PROCEDURE WAS LAP SIGMARECTION. A GRASPER WAS BEING USED AT THE TIME OF THE INCIDENT AND [BRAND NAME GRASPER] WAS BEING USED PRIOR TO THE INCIDENT. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGE COMPONENT. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561493 ↗
• MalfunctionMar 10, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HERNIA EVENT DESCRIPTION: DURING INSERTION OF A FLEXIBLE PROSTHETIC MESH USING A FENESTRATED LAPAROSCOPY JAW IN THIS TROCAR, FOR INGUINAL WALL REINFORCEMENT, SEVERAL PARTS OF THE VALVE HAVE BECOME SEPARATED AND FINISH IN THE ABDOMINAL CAVITY OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28FEB25: NOT ALL THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT¿S ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 10MAR25: THE PART CONCERNING IS THE WHITE PART OF THE SEAL IN FRENCH ¿LA COLLERETTE BLANCHE¿. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560840 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC NEPHRECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, WHEN THEY WERE TAKING THE TROCAR OUT, THEY SAW THE SEAL WAS INSIDE THE PATIENT. THEY REMOVED THE SEAL. PER ACCOUNT MANAGER, THE INNER SEAL WAS NOT THE PLASTIC PART NOR THE DUCKBILL. ACCOUNT MANAGER BELIEVES IT WAS THE SEPTUM. NO ADVERSE REACTION TO THE PATIENT. ACCOUNT MANAGER CONFIRMED IT WAS ONLY ONE DEVICE MALFUNCTION. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE: THE TABS WERE NOT BEING PINCHED AT THE TIME OF BREAKAGE. YES, ALL PIECES WERE REMOVED FROM THE PATIENT. THE BROKEN PIECE OF THE TROCAR IS BLACK. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT TO INSPECT THE DAMAGED COMPONENT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 04MAR2025: THE TIMING OF THE EVENT WAS SOMETIME DURING THE CASE. THEY DID NOT NOTICE UNTIL THEY SAW THE PIECE INSIDE THE PATIENT. NO, THE ENTIRE SEAL HOUSING OR CAP DID NOT DETACH. YES, ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE ENTIRE COMPONENT FELL OUT. THE COMPONENT WAS THE INNER SEAL, NOT THE LARGER BLACK ONE, BUT THE ONE INSIDE THAT IS A GRAY FUNNEL LOOKING UNIT AND A CLEAR PIECE. THE COLOR WAS CLEAR AND GRAY. IT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560559 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  PROCEDURE PERFORMED: LOBECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, THE TROCAR WAS USED FOR SCOPE PORT AND WAS PLACES BETWEEN THE PATIENT RIBS. THE OPERATING ROOM STAFF HEARD A CRACK NOISE AND NOTICED THAT THE TROCAR IS BROKE INTO 2 PIECES. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 05MAR25: THERE WAS NO PATIENT INJURY, THEY WAS RELEASED HOME. THE BREAK OCCURRED AT THE SHAFT. THE TROCAR WAS ROTATED ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTION WITH NO DIFFICULTY INSERTION. THE BREAK WAS CONSIDERED A CLEAN BREAK WITH NO PARTICULATION. LAPAROSCOPE WAS INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. INTERVENTION: USE A REPLACEMENT. PATIENT STATUS: NO INJURY WAS RELEASED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560332 ↗
• MalfunctionJan 29, 2025Fracture; Fracture

  PROCEDURE: UNKNOWN. EVENT DESCRIPTION: THE DEVICE WAS USED INTRAOP - DID NOT APPEAR TO BE USING EXCESSIVE FORCE OR LEVERING ANYTHING AND THE PORT BROKE DURING THE OPERATION. ANOTHER ONE OF THE SAME LOT NUMBER WAS OPENED AND USED TO COMPLETE THE OPERATION (LOT 1527761). ADDITIONAL INFORMATION WAS PROVIDED AS PCF AMA TERRITORY MANAGER ON (B)(6) 2025 SURGEON WAS USING TROCAR AS CAMERA PORT. SURGEON WAS LOOKING AROUND ABDOMINAL CAVITY AS NORMAL WHEN SHE HEARD A CRACK. SURGEON WAS LOOKING AROUND ABDOMINAL CAVITY AS NORMAL WHEN SHE HEARD A CRACK. REPORTING SURGEON AND NURSE STATED NO UNDUE FORCE WAS BEING APPLIED, AND SHE WAS ARTICULATING SCOPE AS NORMAL. NIL EXCESSIVE LEVERAGING OF THE SCOPE. PORT CRACKED IN HALF TOWARDS THE SEAL HOUSING AS PER IMAGE. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. USER REMOVED TROCAR AND REPLACED WITH ANOTHER CTF73 TO RESOLVE THE SITUATION. NIL ISSUES. SCOPE IN PORT WAS THE OTHER INSTRUMENT USED WHEN THE EVENT OCCURRED. INTERVENTION: USER REMOVED TROCAR AND REPLACED WITH ANOTHER CTF73. NIL ISSUES. ANOTHER ONE WAS OPENED. LOT NUMBER WAS THE SAME 1527761. PATIENT STATUS: STABLE. THE DATE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265005 ↗
• MalfunctionJan 21, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY SURGERY. EVENT DESCRIPTION: DR. [NAME] FROM [HOSPITAL NAME] PERFORMED A CHOLECYSTECTOMY SURGERY. AT THE END OF THE PROCEDURE, WHEN HE WAS WITHDRAWING THE TROCARS FROM THE ABDOMINAL INCISION, HE SUDDENLY NOTICED A SMALL PIECE OF THE TROCAR INSIDE THE INCISION. THE SURGEON REMOVED THE PIECE AND ONLY THEN CLOSED THE INCISION. OTHER SLEEVES OF THE 12X100 TROCARS (CTS22). THEY WERE UNABLE TO TELL ME WHETHER THIS BROKEN TROCAR IS THE FULL TROCAR CTF73 OR THE SEPARATE SLEEVE (CTS22). I SUSPECT IT WAS THE FULL TROCAR, AS EARLIER THIS WEEK, A REPORT FROM THE SAME HOSPITAL WAS RECEIVED ABOUT TWO FAULTY TROCARS FROM THE SAME BATCH. ADDITIONAL INFORMATION PROVIDED BY DISTRIBUTOR ON 06JAN2025: THE BEND/BREAK CAUSED PARTICULATION. ONE PIECE OF THE SLEEVE, WHERE THE FUNNEL IS CONNECTED, WAS BROKEN. A PIC WAS TAKEN. YES, ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE BEND/BREAK TOOK PLACE WHERE THE FUNNEL IS CONNECTED, THE SIDE OF THE SLEEVE. SHOWN IN THE PIC. THE BEND/BREAK WAS IDENTIFIED DURING THE REMOVAL OF THE TROCAR AT THE END OF THE SURGERY. THE TROCAR ROTATED IN ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTION DURING INSERTION. THERE WAS NO DIFFICU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201275 ↗
• MalfunctionJan 7, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: ROBOT CHOLE. EVENT DESCRIPTION: TROCAR SNAPPED IN HALF INSIDE PATIENT DURING PROCEDURE. NO PATIENT INJURY, ALL PLASTIC REMOVED FROM CAVITY. BROKE AT THE CANNULA. PRODUCT IS AVAILABLE FOR RETURN; MAY ONLY BE ONE PIECE. ADDITIONAL INFORMATION PROVIDED BY HOSPITAL REPRESENTATIVE ON 03JAN2025 VIA EMAIL: LOT: 1522410 PROCEDURE WAS ROBOT CHOLE I WAS TOLD THAT THE PATIENT WAS [REDACTED] AND THERE WAS A METAL ROBOTIC TROCAR INSIDE OF IT. YES, THE DEVICE WILL BE RETURNING. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092733 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC CHOLECYSTECTOMY. EVENT DESCRIPTION: THE TROCAR HAD BEEN INSERTED DURING A ROBOTIC CHOLECYSTECTOMY TO USE FOR THE RETRIEVAL BAG TO REMOVE THE SPECIMEN. A RETRIEVAL BAG [MODEL NAME] WAS INSERTED INTO THE TROCAR. UPON INSERTION OF THE RETRIEVAL BAG THROUGH THE PORT IT WAS NOTICED THAT THE INTERNAL RUBBER VALVE DETACHED FROM THE PORT AND FELL INTO THE PATIENT ABDOMEN. NO CLINICAL IMPACT ON THE PATIENT. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21087233 ↗
• MalfunctionNov 7, 2024Optical Distortion; Optical Distortion

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: EVENT DATE: 14OCT2024. MODEL #: CTF73. [HOSPITAL NAME] IN [CITY AND STATE] UTILIZED ONE OF OUR CTR03 TROCARS ON (B)(6). THE TROCAR TRIAL WAS TO START ON 10/14, BUT THE SURGEON UTILIZED WITHOUT OUR KNOWLEDGE. DURING EDUCATION TABLE, SHE CLAIMED TO HAVE PRIOR EXPERIENCE WITH THEM. DR. [NAME] FOUND THAT THE ¿CHEAP PLASTIC DIAPHRAGM MAKES IT DIFFICULT TO PASS CLIPS AND TEARS EASILY, SCATTERING BITS OF PLASTIC IN THE PATIENT. I HAD TO RETRIEVE TWO PIECES OF PLASTIC ON MY LAP CHOLE TODAY AND HAVE PHOTOS OF THE PLASTIC AND OF THE TORN-UP DIAPHRAGM OF THE TROCAR WITH MISSING PIECES OF PLASTIC FROM ROUTINE INSTRUMENT PASSING OF A CLIP APPLIER." THE PHYSICIAN ALSO STATED THAT THE OPTICAL TIP HAD AN INFERIOR TIP, MAKING IT UNSAFE DUE TO POOR VISIBILITY. THE TROCAR WALLS DON¿T GRIP TISSUE AND SLIDE IN/OUT. PRODUCT CANNOT BE LOCATED AND WILL NOT RETURN. ADDITIONAL INFORMATION OBTAINED FROM APPLIED REPRESENTATIVE ON 15OCT2024: THE PIECES OF THE TROCAR THAT BROKE OFF WERE REMOVED LAPAROSCOPICALLY. THE PATIENT IS FINE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH [COMPETITOR DEVICE] 12MM TROCAR. NO INTERNAL SEAL COMPONENTS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20636374 ↗
• MalfunctionOct 8, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  PROCEDURE PERFORMED: UNILATERAL ADRENALECTOMY IN PRONE POSITION. EVENT DESCRIPTION: COMPLAINT (B)(4) (1 OF 2), MFR REPORT NUMBER 2027111-2024-00863. COMPLAINT (B)(4) (2 OF 2), MFR REPORT NUMBER 2027111-2024-00863. THE TROCAR BROKE IN THE MIDDLE PART DURING THE OPERATION AND WAS DISCOVERED ON REMOVAL WHEN HALF OF THE TROCAR GOT STUCK IN THE PORT HOLE. IT IS UNCLEAR WHEN DURING THE OPERATION THE TROCAR BROKE. TWO DIFFERENT ARTICLE NUMBERS ARE SENT IN BY THE CUSTOMER. THE CUSTOMER WILL SEND IN 2 ART NO (CTS22 AND CTF73) LOT NO 1525327 AND LOT NO 1514216. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27SEP24: THE APPLIED MEDICAL REPRESENTATIVE HAD SPOKEN WITH THE NURSE IN CHARGE TODAY EARLIER TO CONFIRM THE FOLLOWING - BOTH DEVICES BROKE DURING THE SAME PROCEDURE ON (B)(6) 2024. AWARE DATE WAS UPDATED ON 26SEP24 FOR BOTH COMPLAINTS. NO PATIENT INJURY AND BROKE PIECE WAS RETRIEVED AFTER SURGERY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 01OCT24: NO PATIENT WAS HARMED AND NOT A ROBOTIC SURGERY. INTERVENTION: BROKE PIECE WAS RETRIEVED AFTER SURGERY. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403379 ↗
• MalfunctionSep 20, 2024Break; Break

  PROCEDURE PERFORMED: LAP ADRENALECTOMY. EVENT DESCRIPTION: DESCRIPTION: SURGEON COMPLETED CASE IN PRONE POSITION AND UPON PULLING OUT THE TROCAR, THE TROCAR SLEEVE BROKE IN HALF LEAVING HAVE IN THE SKIN LEVEL OF THE PATIENT. THE FULL PIECE WAS ABLE TO BE RETRIEVED EASILY WITH NO HARM TO PATIENT AT END OF PROCEDURE. THE NURSE SAVED THE PIECES FOR RETURN AND HAVE BEEN PLACED IN OFFICE IN A BIOHAZARD BAG. PLEASE SEND LABEL TO [NAME] WHO IS COPIED ON THIS EMAIL AND SHE WILL ASSIST IN THE RETURN OF THE BROKEN TROCAR. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 27AUG2024 VIA EMAIL: TROCAR WAS INSERTED IN STANDARD 10/2 FASHION WITH OBTURATOR IN PLACE WITH NO PROBLEMS. NO DIFFICULTY DURING INSERTION. THE BREAK WAS CONSIDERED A CLEAN BREAK. TROCAR WAS NOT USED WITH A ROBOT. OBTURATOR WAS NOT INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. INTERVENTION: THE FULL PIECE WAS ABLE TO BE RETRIEVED EASILY WITH NO HARM TO PATIENT AT END OF PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273790 ↗
• MalfunctionSep 10, 2024Break; Fracture; Break; Fracture

  PROCEDURE PERFOMED: OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIB THORACOSCOPY. EVENT DESCRIPTION: TROCAR SNAPPED IN HALF. IT WAS A CLEAN BREAK, NOTHING WAS LEFT IN THE PATIENT. NO PATIENT INJURY. THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) VIA EMAIL ON 22AUG2024: THE DEVICE WAS REPLACED WITH A NEW CTF73 DURING THE CASE. THE PROCEDURE BEING PERFORMED WAS AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIB THORACOSCOPY. THE BREAK OCCURRED AT THE SHAFT OF THE TROCAR. THE BREAK WAS IDENTIFIED DURING THE CASE. THE BREAK DID NOT CAUSE PARTICULATION. THE TROCAR WAS NOT USED WITH A ROBOT. THE LOT NUMBER IS 1519892. INTERVENTION: THE DEVICE WAS REPLACED WITH A NEW CTF73 DURING THE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185941 ↗
• MalfunctionJul 26, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPY. EVENT DESCRIPTION: DURING SURGERY, TROCAR MODEL CTF73 BROKE OFF INSIDE PATIENT. MORE INFORMATION TBA. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 16JUL2024 VIA EMAIL: DAY OF SURGERY: (B)(6) 2024, SURGEON NAME: DR. (B)(6), CASE BEING PERFORMED: LAPAROSCOPY, ANY INJURIES TO THE PATIENT: NOT AT THIS TIME DURING THE PROCEDURE THE TROCAR WAS FULLY INTACT. TOWARDS THE END OF THE CASE, IT WAS NOTICED THE TIP OF THE TRACAR WAS CRACKED AND A PORTION OF IT BROKE OFF. SURGEON FINISHED THE CASE BY REMOVING THE TROCAR AND REPLACING IT WITH A NEW ONE. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 17JUL2024 VIA EMAIL: [HOSPITAL] WOULD LIKE TO REPLACE THE 1 TROCAR INVOLVED ALONG WITH THE REMAINING 16 STERILE TROCARS WITH THAT SPECIFIC LOT NUMBER. THEY WOULD APPRECIATE A RETURN LABEL AND A BOX. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 24JUL2024 VIA EMAIL: NO PIECES RETRIEVED FROM THE PATIENT. THE DISTAL TIP OF THE TROCAR HAD A 1-2MM PIECE BROKEN OFF. THE PIECE WAS THE CLEAR DISTAL TIP. INTERVENTION: REMOVED THE TROCAR AND REPLACED IT WITH A NEW ONE. PATIENT STATUS: NO PATIENT INJURY AT THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19845709 ↗