Kii Fios First Entry CTF33Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00607915124212), received between Feb 24, 2016 and Aug 19, 2026 — classified as 1 death, 60 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (24 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334140 ↗
• MalfunctionJun 16, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: [TRANSLATION] 11 MM TROCAR. COMPLAINT: THE VALVE HAS COME LOOSE. HOW THIS HAPPENED IS A MYSTERY. AS A RESULT, IT HAS ENDED UP LOOSE INSIDE THE ABDOMEN. CONSEQUENTLY, THERE IS NO LONGER ANY AIR IN THE ABDOMEN. UNFORTUNATELY, THE DEPARTMENT NO LONGER HAS THE OUTER PACKAGING. ONLY THE (DIRTY) TROCAR REMAINS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28MAY26: THE VALVE HAS COME LOOSE. HOW THIS HAPPENED IS A MYSTERY. AND AS A RESULT, IT ENDED UP LOOSE INSIDE THE BELLY. BECAUSE OF THIS, THERE IS NO MORE AIR IN THE BELLY. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526969 ↗
• MalfunctionApr 29, 2026Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY LAPAROSCOPIC VS OPEN. EVENT DESCRIPTION: TIP OF TROCAR CAME OFF UPON ENTRY. 11/100MM FIOS FIRST ENTRY. PICTURE BELOW WITH DETAILS. I WAS NOT IN PROCEDURE. SPOKE TO DR. AND HE SAID HE WASN¿T BEING FORCEFUL. TIP OF OBTURATOR CAME OFF IN ABDOMEN, AND SCOPE PUSHED THROUGH. WAS ABLE TO RETRIEVE OBTURATOR TIP LAPAROSCOPICALLY. PATIENT WAS NOT INJURED AND DOING OK. HOSPITAL HAS TROCAR TO BE RETURNED HOWEVER NURSE DID NOT GRAB THE PIECE THAT BROKE OFF. ADDITIONAL INFORMATION PROVIDED BY [APPLIED MEDICAL REPRESENTATIVE] ON 23APR2026 VIA EMAIL: FOLLOWING UP ON YOUR QUESTIONS AND SPEAKING DIRECTLY TO [DOCTOR]. ZERO OBTURATOR INSERTED TO ANOTHER CANNULA. THE ONLY TROCAR THAT WAS USED WAS WITH THAT ONE OBTURATOR. NOTICED DURING USE. IT WAS IDENTIFIED WHEN THE SURGEON HAD TROUBLE INSERTING AND PULLED OUT AND TRIED ANOTHER SPOT BECAUSE WAS DIFFICULT TO GO IN. IT WAS JUST THE SCOPE THAT WAS TRYING TO PUSH IT¿S WAY IN. NOTICED IT THEN AND WAS ABLE TO RETRIEVE THE TIP. INSERTED THROUGH THE TISSUE LAYERS OPTICALLY. THE DIFFICULTY FROM INSERTION WAS BECAUSE THE TIP CAME OFF. AGAIN, DIDN¿T NOTICE TILL PULLED OUT AND TRIED ANOTHER PORT SITE. INTERVENTION: WAS ABLE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033919 ↗
• MalfunctionMar 2, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: INGUINAL HERNIA REPAIR. EVENT DESCRIPTION: BROKE OFF INSIDE OF PATIENT. NEEDED X-RAY TO CONFIRM REMOVED FROM PATIENT. NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON 18FEB2026 VIA EMAIL (ENTERED BY APPLIED MEDICAL REPRESENTATIVE): THEY MISSPOKE ON WHAT HAPPENED IN THE PROCEDURE. THEY PUSHED THE MESH DOWN THE 11MM TROCAR, AND THE SEAL FELL OFF THROUGH THE OBTURATOR. IT APPEARS THAT THERE WAS NO BENDING IN THE TROCAR JUST A SEAL BEING BROKEN. NO, THE BEND/BREAK DID NOT CAUSE PARTICULATION. YES, ALL PIECES REMOVED FROM THE PATIENT. NO BEND OR BREAK JUST SEAL ISSUE. TROCAR WAS INSERTED PROPERLY. NO DIFFICULTY DURING INSERTION. NO ROBOT. NO, THE OBTURATOR WAS NOT INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491976 ↗
• MalfunctionFeb 20, 2026Fracture

  PROCEDURE PERFORMED: LAP WASHOUT + BILIARY STINT. EVENT DESCRIPTION: TROCAR SNAPPED. TOTAL TROCAR RETRIEVED IN FULL. FURTHER DETAILS TO BE CONFIRMED BY SCRUB NURSE. PATIENT STATUS: NO EFFECT FROM EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402610 ↗
• MalfunctionFeb 9, 2026Material Fragmentation

  PROCEDURE PERFORMED: SUBLAY-OP. EVENT DESCRIPTION: THE DEVICE WAS USED CORRECTLY. THE CUSTOMER HAS BEEN USING IT FOR MANY YEARS AND IS FAMILIAR WITH ITS HANDLING. AFTER THE SKIN INCISION, THE TROCAR WAS INSERTED INTO THE ABDOMINAL WALL WITH AN OPTICAL SYSTEM/CAMERA, WHERE THE INCIDENT WAS DISCOVERED: THE TROCAR TIP HAD BROKEN OFF. PATIENT STATUS: NO PATIENT INJURY NOR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292867 ↗
• MalfunctionJun 26, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC ENDOMETRIOSIS ABLATION. EVENT DESCRIPTION: THE TROCAR WAS BEING USED FOR UMBILICAL ENTRY. BEFORE GAINING ACCESS INTO THE ABDOMEN, THE TIP OF THE OBTURATOR APPEARED TO SHATTER WITHIN THE ABDOMINAL WALL LAYERS PRIOR TO GAINING FULL ENTRY. ALL FRAGMENTS OF THE OBTURATOR WERE REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 25JUN25: THE STANDARD TROCAR INSERTION TECHNIQUE I USE INVOLVES ROTATION IN ALTERNATING CLOCKWISE AND COUNTERCLOCKWISE DIRECTIONS, AND THIS WAS THE METHOD EMPLOYED AT THE TIME OF ENTRY. IN THIS INSTANCE, THE ISSUE AROSE BECAUSE THE TROCAR BECAME JAMMED INSIDE THE PORT. WHEN IT WAS REMOVED¿AT THE UMBILICAL INCISION AND NOT WHILE INSIDE THE PELVIC CAVITY¿IT REQUIRED MORE FORCE THAN USUAL, RESULTING IN THE TROCAR BREAKING. WHILE THIS OCCURRED OUTSIDE OF THE PELVIC CAVITY BUT AT THE UMBILICAL INCISION, WE CANNOT DEFINITIVELY EXCLUDE THE POSSIBILITY THAT A SMALL FRAGMENT MAY HAVE BEEN RETAINED INTRA-ABDOMINALLY. THE BREAK WAS NOT A CLEAN BREAK BUT PARTIALLY BROKEN/CRACKED. THE TROCAR AS NOT USED WITH A ROBOT. INTERVENTION: THE DEVICE WAS REPLACED WITH THE SAME MODEL TROCAR AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342139 ↗
• MalfunctionApr 21, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: WHEN OPENING THE TROCAR, THE SURGEON'S ASSISTANT NOTICED A PIECE OF PLASTIC INSIDE THE CANNULA, WHICH PREVENTED THE OBTURATOR FROM BEING INSERTED. THEY HAD TO OPEN A NEW TROCAR TO REPLACE IT. IT SHOULD BE NOTED THAT UPON RECEIPT AND VERIFICATION OF THE PRODUCT, IT DOES INDEED HAVE A PIECE OF PLASTIC GLUED INTERNALLY. INTERVENTION: THEY HAD TO OPEN A NEW TROCAR TO REPLACE IT. PATIENT STATUS: NA (BEFORE USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877338 ↗
• MalfunctionFeb 3, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: DIAGNOSTIC LAPAROSCOPY AND APPENDECTOMY. EVENT DESCRIPTION: USER REPORTED BY EMAIL THAT A PLASTIC PART BROKE FROM THE TIP OF THE SHEETH. I AM IN CONTACT TO RECEIVE FURTHER INFORMATION. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27JAN25: THE TM WAS MADE AWARE THAT PARTS OF THE OBTURATOR TIP CAME OFF WHILE INSERTING THE TROCAR USING FIOS INTO THE PATIENTS' ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28JAN25: UPDATED PROCEDURE - DIAGNOSTIC LAPAROSCOPY AND APPENDECTOMY, CONCOMITANT DEVICE. THE CTF33 WAS USED AS FIOS FIRST ENTRY AS USUAL WITH A 10 MM OPTIC. DUE TO THE VERY THICK ABDOMINAL WALL, IT WAS NOT POSSIBLE TO PLACE THE TROCAR EVEN WITH GREAT FORCE. THE HEAD PHYSICIAN WAS CALLED TO THE OPERATING ROOM, WHO THEN DECIDED ON A MINILAP AS THE FIRST ACCESS. THE CTF33 WAS THEN PLACED UNDER VISUALIZATION AS A WORKING TROCAR. THE DAMAGE TO THE OBTURATOR WAS NOTICED AND THE INITIAL ACCESS WAS SEARCHED FOR ANY REMAINING PLASTIC PARTS. DUE TO THE SPECIAL ANATOMY, HOWEVER, NO PARTS COULD BE FOUND. TM CONFIRMED 'TIP OF SHEETH' WAS MEANT THE TIP OF THE OBTURATOR. THE BREAK WAS NOT CONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298453 ↗
• MalfunctionJan 21, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: THE TOP OF THE SEAL WAS REMOVED DURING THE END OF THE PROCEDURE AND THE TOP PIECE BROKE OFF THE SIDE THAT HOLDS THE SEAL IN PLACE (PLASTIC COMPONENT). PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201276 ↗
• MalfunctionDec 2, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: "ON (B)(6) 2024 @ 1140 HRS ,PATIENT, FEMALE, HAD EMERGENCY LAPAROSCOPIC CHOLECYSTECTOMY IN OT 5 AT 1215HRS", "WHILE SURGERY ON GOING APPLIED MEDICAL KII FIOS BLADE LESS TROCAR 10 MM SLEEVE BROKEN IN TO TWO PIECES, PATIENT WAS STABLE, NO INCIDENT OF ANY ANAPHYLACTIC REACTION, IMMEDIATELY COMPLETE TROCAR REMOVED, CLEANED THE WOUND WITH BETADINE, AND REPLACED WITH ANOTHER BRAND TROCAR. SURGERY FINISHED AT 1425HRS, DETAIL OF THE CONSUMABLE: KII FIOS, FIRST ENTRY, REF CTF 33, EXPIRY :11/07/2027." INTERVENTION: IMMEDIATELY COMPLETE TROCAR REMOVED, CLEANED THE WOUND WITH BETADINE, AND REPLACED WITH ANOTHER BRAND TROCAR. PATIENT STATUS: PATIENT WAS STABLE, NO INCIDENT OF ANY ANAPHYLACTIC REACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821141 ↗
• MalfunctionSep 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: COMPLAINT (B)(4), COMPLAINT 1 OF 3. (MFR REPORT # 2027111-2024-00815) COMPLAINT (B)(4), COMPLAINT 2 OF 3. (MFR REPORT # 2027111-2024-00816) COMPLAINT (B)(4), COMPLAINT 3 OF 3. WHEN LODGING COMPLAINT (B)(4), IT WAS CUSTOMER REMARKS WERE NOTICED ON THE PCF THAT THERE HAVE BEEN MULTIPLE CTF33 AND C0R47 PORTS WITH THE SAME ISSUE IN RECENT WEEKS. WHEN THE AMNZ TERRITORY MANAGER WAS APPROACHED TO OBTAIN FURTHER INFORMATION ON THE ADDITIONAL INCIDENTS, SHE REACHED OUT TO THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION THAT WAS PROVIDED VIA EMAIL ON 27-AUG-2024. "I HAVE SPOKEN TO THE ACCOUNT, AND THEY KNOW OF 3 TOTAL INCIDENTS. SO FAR: 2 X CTF33 AND 1 X C0R47. IN ALL CASES, THEY CONTINUED USING THE TROCAR DESPITE THE RESISTANCE." THE FOLLOWING ARE THE COMPLAINTS RAISED SO FAR. 1 X CTF33 - COMPLAINT (B)(4) 1 X C0R47 - COMPLAINT (B)(4). 1 X CTF33 - COMPLAINT (B)(4). PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185997 ↗
• MalfunctionAug 29, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: TLH. EVENT DESCRIPTION: COMPLAINT (B)(4), COMPLAINT 1 OF 3. COMPLAINT (B)(4), COMPLAINT 2 OF 3. COMPLAINT (B)(4), COMPLAINT 2 OF 3. THE TROCAR WAS BEING USED TO GAIN ACCESS FOR THE TLH FOR DR (B)(6) AND (B)(6). SURGEON EXPERIENCED RESISTANCE WHEN INSERTING CAMERA INTO THE PORT. THE SURGEON EXPRESSED, "IT DID NOT SLIDE IN LIKE IT USUALLY DOES AND FELT TOO TIGHT." THE SURGEON NEEDED TO TWIST AND EXERT PRESSURE TO GET THE CAMERA THROUGH THE PORT SLEEVE. THERE HAVE BEEN MULTIPLE CTF33 AND C0R47 PORTS WITH THE SAME ISSUE IN RECENT WEEKS. ALL USED PORTS HAVE BEEN DISCARDED. (B)(4), AMNZ TERRITORY MANAGER HAD REQUESTED THAT THEY PLEASE KEEP THE USED TROCARS SHOULD THIS HAPPEN AGAIN. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. CAMERA FORCE AND MANIPULATION WAS USED TO RESOLVE THE SITUATION. ADDITIONAL INFORMATION WAS PROVIDED BY AMNZ TERRITORY MANAGER VIA EMAIL ON 20-AUG-2024 STATING THAT A SEPARATE CER SHALL BE SUBMITTED FOR THE ADDITIONAL CODE C0R47. ADDITIONAL INFORMATION WAS PROVIDED BY AMNZ TERRITORY MANAGER RECEIVED VIA EMAIL ON 21-AUG-2024. "SAME CAMERA AS NORMAL (AS FAR AS I'M AWARE) AND IT FELT LIKE THE CAMERA WAS CATCHING ON THE RUBB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20102685 ↗
• MalfunctionAug 23, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: GYNECOLOGICAL LAPAROSCOPY. EVENT DESCRIPTION: [TRANSLATION] DURING GYNECOLOGICAL LAPAROSCOPY: WHEN THE OPTICAL TROCAR WAS BEING READJUSTED FOR INSUFFLATION OF THE PERITONEAL CAVITY, THE TWO LUGS SNAPPED OFF. ONE OF THEM "JUMPED" OUT OF THE FIELD, THE SECOND INTO THE GOWN AND IS RETAINED THERE WHILE STILL IN THE PATIENT'S ABDOMEN. WITHDRAWAL OF EQUIPMENT AND VERIFICATION OF PRESENCE OF ALL COMPONENTS. OPERATIVE TIME EXTENDED FOR INSPECTION. ADDITIONAL INFORMATION WAS RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA PRODUCT COMPLAINT FORM ON 14AUG24: AT THE END OF THE PROCEDURE, WHEN THE REDUCER WAS REMOVED TO INSUFFLATE THE ABDOMEN, THE TWO LUGS HOLDING THE REDUCER BROKE CLEANLY. DURING A GYNECOLOGICAL LAPAROSCOPY: WHEN THE OPTICAL TROCAR WAS MISADAPTED FOR INSUFFLATION OF THE PERITONEAL CAVITY, THE TWO LUGS BROKE CLEANLY. ONE OF THEM "JUMPED" OFF-CAMERA, THE SECOND INTO THE SHIRT AND WAS HELD THERE WHILE IT WAS STILL IN THE PATIENT'S ABDOMEN. REMOVAL OF EQUIPMENT AND VERIFICATION OF THE PRESENCE OF ALL ELEMENTS. NO CLINICAL IMPACT TO THE PATIENT. REMOVAL OF THE TROCAR AND RECOVERY OF THE ELEMENTS BY EXPLORING THE ABDOMINAL CAVITY. EXTENSION OF OPERATING TIME F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049632 ↗
• MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP APPENDECTOMY EVENT DESCRIPTION: A GAUZE WAS INSERTED WITH A GRASPER THROUGH THE TROCAR, AND THE SEAL COMPLETELY FELL INTO THE ABDOMEN. A GAUZE WAS INSERTED WITH A GRASPER THROUGH THE TROCAR, AND THE SEAL COMPLETELY FELL INTO THE ABDOMEN. THE SEAL WAS REMOVED FROM THE ABDOMEN. THE TROCAR WAS PART OF GK880 KIT TYPE OF INTERVENTION: THE SEAL WAS REMOVED FROM THE ABDOMEN PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955992 ↗
• MalfunctionJul 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP HYSTERECTOMY. EVENT DESCRIPTION: I HAD AN INCIDENT OF SEAL CAME OFF FROM THE TROCAR(WHITE) WHILE OPERATING. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 05JUL24: UPDATED MODEL NUMBER WITH UNKNOWN LOT NUMBER, PROCEDURE AS LAP HYSTERECTOMY, EVENT DATE. IT IS THE ENTRY POT AND WHEN WE CLEANED THE POT WITH TONSIL SWAB, THE ENTIRE CLEAR SEAL CAME OFF. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 11JUL24: UPDATED LOT NUMBER. INTERVENTION: CLEAR PLASTIC SHIELD WAS RETRIEVED AT THE END OF THE PROCEDURE. PATIENT STATUS: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851886 ↗
• MalfunctionJun 18, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: RUPTURED ECTOPIC. EVENT DESCRIPTION: THE TIP OF A TROCHAR SHATTERED TONIGHT DURING INSERTION LEAVING MULTIPLE PLASTIC FRAGMENTS IN THE UMBILICAL WOUND. WE THINK WE HAVE RETRIEVED THEM ALL BUT THESE DO NOT SHOW UP ON XRAY. I WAS DOING A RUPTURED ECTOPIC TONIGHT WITH MY REGISTRAR AND SHE HAD DIFFICULTY INSERTING THE 10MM TROCHAR THROUGH THE UMBILICUS USING THE CORRECT TECHNIQUE SO WE CONVERTED TO VEREES AND 5MM TROCHAR. WHEN WE TOOK THE 10 AGAIN FOR SUPRAPUBIC ENTRY AGAIN WE HAD DIFFICULTY AND ON REMOVAL NOTICED THE INTRODUCER HAD SHATTERED. WE HAD NOT ENTERED THE ABDOMEN SUPRAPUBICALLY SO CHECKED AND THERE WERE NO FRAGMENTS THERE. WE CHANGED TROCHAR AND INSERTED THIS WITHOUT DIFFICULTY. AT THE END OF THE CASE WE REASSESSED THE UMBILICAL WOUND AND REMOVED SEVERAL PLASTIC FRAGMENTS. WE HAD CHECKED WITH XRAY BUT THE TROCHAR DOES NOT SHOW UP SO WE DID NOT PERFORM AN INTRA-OP XRAY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 05JUN24: UPDATED LOT NUMBER. IT WAS NOT A ROBOTIC CASE. AT THIS POINT IN TIME THE APPLIED MEDICAL REPRESENTATIVE WAS UNABLE TO RETRIEVE FURTHER INFORMATION REGARDING PATIENT RELATED, STATUS, WHETHER IT WAS OBTURA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563806 ↗
• MalfunctionDec 19, 2023Break; Break

  PROCEDURE PERFORMED: LAP ENDOMETRIOSIS EVENT DESCRIPTION: I BELIEVE THE DAMAGE IS A CRACK DOWN THE SIDE OF THE TROCAR WHEN THEY WERE TRYING TO REMOVE THE SPECIMEN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20DEC23: THE BREAK IS ONE THE SIDE BUTTONS ON THE CANNULA. THE TROCAR WAS INSERTED AT A 10 TO 2 MOTION. THERE WAS NO DIFFICULTY WITH INSERTION. THE BREAK WAS CONSIDERED A CLEAN BREAK. THE PIECE SNAPPED OFF THE CANNULA. NO PARTICULATION OCCURRED. ALL PIECES WERE REMOVED FROM THE PATIENT. THE TROCAR WAS NOT USED WITH A ROBOT. PATIENT STATUS: NO CLINICAL IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361163 ↗
• MalfunctionNov 20, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: "LAST FRIDAY DR [NAME] USED ONE CTF33 DURING HER CASE AND ONCE SHE INSERTED THE TROCAR THEY NOTICED BLOOD INSIDE THE TROCAR, THE BLUNT TROCAR IS BROKEN AND SHARP ON THE DISTAL TIP. THEY CHECKED THE PACKAGING AND PATIENT FOR THE MISSING PLASTIC PIECES AND NO TRACES FOUND" PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 15NOV2023 PER HEALTH CANADA REPORT # 1070351: [TRANSLATION OF INCIDENT DESCRIPTION] THE SURGEON NOTICES WHEN SHE ENTERS THE OPERATING LENS WITH THE TROCAR THAT THERE IS LIQUID COMING OUT THROUGH THE FIRST ENTRY TROCAR. THIS IS NOT NORMAL BUT STILL DOES THE SURGERY BEFORE THE TROCAR. AT THE END OF THE CASE WE NOTICED THAT A SMALL PIECE OF PLASTIC WAS MISSING FROM THE TROCAR CANNULA. IT IS ASSUMED THAT THE PIECE OF PLASTIC WAS MISSING BEFORE SURGERY BUT WE ARE NOT CERTAIN. THE SURGEON CHECKED THE ABDOMEN AND FOUND NO PLASTIC PIECES IN THE ABDOMEN. ADDITIONAL INFORMATION RECEIVED ON 16NOV2023 VIA EMAIL FROM ACCOUNT MANAGER: NO PATIENT INJURY OCCURRED. DISTAL TIP OF OBTURATOR BROKE. THE TROCAR WAS INSERTED USING THE RECOMMENDED TECHNIQUE. THERE WAS NO DIFFICULTY DURING INSERTION. THE CASE WAS NOT ROBOTIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173085 ↗
• MalfunctionAug 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: TODAY A TROCAR MADE BY APPLIED MEDICAL 11X100MM FIRST ENTRY REF # CTF33 LOT# 1488458 EXPIRATION DATE 4-7-2026 WAS IN PATIENT. DR. [NAME] INSERTED THE CADIERE FORCEP AND A PIECE OF THE GASKET BROKE OFF FROM INSIDE THE TROCAR. THE PIECE WAS RETRIEVED AND TROCAR REMOVED FROM PT, TAGGED AND BAGGED AND GIVEN TO YOU TO REPORT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 08AUG2023 VIA EMAIL FROM APPLIED ACCOUNT MANAGER: ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE COLOR OF THE PIECE WAS BOTH BLACK AND CLEAR. THE CLEAR SHIELD AND DUCKBILL OR SEPTUM WAS RIPPED/TORN AND THE CLEAR SHIELD AND DOUBLE DUCKBILL OR SEPTUM FELL OUT. IT'S HARD TO TELL IF IT WAS THE SEPTUM OR THE DOUBLE DUCKBILL FROM LOOKING THROUGH THE BAG. BY LOOKING AT THE BLACK BROKEN PIECE INSIDE THE BAG, IT LOOKS SIMILAR TO THE PART OF THE DUCKBILL. NO INTERNAL SEAL COMPONENTS WERE REMOVED OR CUT IN ORDER TO INSPECT THE DAMAGED COMPONENT. TYPE OF INTERVENTION: THE PIECE WAS RETRIEVED AND TROCAR REMOVED FROM PT. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550909 ↗
• MalfunctionMar 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE TROCAR DISASSEMBLED DURING SURGERY, RELEASING THE GREEN PLASTIC HALF RING INSIDE THE ABDOMINAL CAVITY. THE MATERIAL THAT FELL INTO THE ABDOMINAL CAVITY WAS COMPLETELY REMOVED BY THE SURGEON. THE PROCEDURE WAS COMPLETED NORMALLY, WITH NO COMPLICATIONS FOR THE PATIENT. THE HOSPITAL DISCARDED THE PRODUCT. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS FOR THE PATIENT. PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED ON 21MAR2023 VIA EMAIL FROM THE DISTRIBUTOR: THE HOSPITAL FOUND THE PRODUCT AND FORWARDED IT TO US. EXPECT PRODUCT RETURN FOR INVESTIGATION. PATIENT STATUS: THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492489 ↗
• MalfunctionJan 13, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP GASTRIC SLEEVE. EVENT DESCRIPTION: A RESIDENT WAS PLACING THE TROCAR (CORRECTLY, BY ALL ACCOUNTS) UNDER DR. [NAME]'S DIRECT SUPERVISION WHEN THE OBTURATOR SNAPPED OFF AT THE TIP OF THE SHAFT. THE OBTURATOR HAD NOT REACHED THE PERITONEUM, SO THE BROKEN PIECE WAS EASILY REMOVED FROM THE INCISION. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 11JAN2023 FROM APPLIED MEDICAL REPRESENTATIVE: THE BREAK OCCURRED AT THE OBTURATOR SHAFT. THE OBTURATOR WAS INSIDE THE CANNULA AT THE TIME OF THE INCIDENT. THERE WERE NO CANNULAS INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. THE BREAK WAS NOT CLEAN, IT WAS JAGGED. THE SNAPPED PIECE WAS RETRIEVED FROM THE PATIENT. THE TROCAR WAS INSERTED "CORRECTLY". THERE WAS NO DIFFICULTY DURING INSERTION. THE CASE WAS NOT ROBOTIC. PRODUCT AVAILABLE FOR RETURN. INTERVENTION: USED ANOTHER TROCAR. PATIENT STATUS: UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164598 ↗
• MalfunctionNov 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: THE TROCAR WAS BEING INSERTED INTO TO THE ABDOMEN. PATIENT WAS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. WHILE INSERTING THE TROCAR INTO THE ABDOMEN, THE VALVE GOT DISLODGED AND FELL INTO THE ABDOMEN. IT WAS DIRECTLY IDENTIFIED AND REMOVED. THE TROCAR, WHICH WAS LEAKING AIR NOW, WAS REMOVED AND REPLACED WITH A NEW ONE. ADDITIONAL INFO RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE ON 12-JAN-23 VIA EMAIL: AFTER CONTACTING THE HOSPITAL TO MAKE SURE THAT THE GIVEN ITEM WAS THE RIGHT ONE, THE HOSPITAL AND MAINLY THE PERSON WHO WAS RESPONSIBLE FOR GIVING IT TO US ASSURED THAT THE CORRECT UNIT WAS GIVEN. THE DR WAS ASKED AGAIN WHAT HE SAW EXACTLY, DR [NAME] SAID THAT THEY SAW SOMETHING LIKE A 'BLACK RUBBER RING' IN THE ABDOMEN, SO THEY DIRECTLY ASSUMED THAT IT FELL FROM THE TROCAR, SINCE ALL TROCARS BEING USED WERE FROM APPLIED MEDICAL. IT WAS MENTIONED TO HIM THAT NONE OF OUR INTERNAL VALVES HAVE A RING-LIKE SHAPE, AND DOCTOR WAS ALSO ASKED FOR A RECORDING OR A SCREENSHOT OF THE PIECE THAT WAS SEEN INSIDE THE ABDOMEN, BUT HE SAID THAT THERE IS NONE. AFTER RETURNING THE UNIT FOR INVESTIGATION AND AFTER MAKING SURE FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798446 ↗
• MalfunctionAug 17, 2022Break; Break

  PROCEDURE PERFORMED: ROBOTIC HIATAL HERNIA EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. AFTER THE TROCAR WAS PLACED IN THE ABDOMEN AND FULLY SEATED, A CAMERA WAS PLACED DOWN THE TROCAR THEN THEY HEARD A POP AND THE TROCAR SNAPPED IN HALF. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A NEW DEVICE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 10AUG2022 VIA PHONE CALL FROM USER FACILITY: INCOMPLETE, (7/8) BREAK OCCURRED IN MIDDLE OF CANNULA AFTER PLACING INSTRUMENT THROUGH CANNULA. THE BREAK DID NOT FRAGMENT. THE TROCAR WAS INSERTED NORMALLY WITH NO DIFFICULTY DURING INSERTION. TYPE OF INTERVENTION: THE CASE WAS COMPLETED WITH A NEW APPLIED TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241394 ↗
• MalfunctionAug 12, 2022Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC GASTRIC SLEEVE. EVENT DESCRIPTION: REP WAS NOT PRESENT FOR THE CASE. DURING THE PROCEDURE THE CANNULA BROKE IN HALF WHILE IN THE PATIENT'S ABDOMEN. A SCOPE WAS INSIDE THE CANNULA AT THE TIME. THE CANNULA BROKE IN THE MIDDLE OF THE SHAFT, THERE WAS NO PARTICULATION. THE TROCAR HAD BEEN INSERTED OPTICALLY. THE SURGEON STATED THAT THEY BELIEVE THE PATIENT'S ANATOMY MIGHT HAVE CONTRIBUTED TO THE INCIDENT. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH AN [NON-APPLIED MEDICAL] TROCAR. PRODUCT IS AVAILABLE FOR RETURN. INTERVENTION: THE CASE WAS COMPLETED WITH AN [NON-APPLIED MEDICAL] TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218484 ↗