Kii Fios First Entry CTF01Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00607915124014), received between Jan 22, 2016 and Sep 29, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941295 ↗
• MalfunctionJan 5, 2026Fracture

  PROCEDURE PERFORMED: DIAGNOSTIC LAPAROSCOPY. EVENT DESCRIPTION: INFORMATION PROVIDED BY AN APPLIED MEDICAL REPRESENTATIVE VIA PHONE (VOICEMAIL) ON 22DEC2025: I GOT NOTIFIED THAT DURING A DIAGNOSTIC LAPAROSCOPY THE CTF01 TROCAR BROKE OFF WHILE USING. IT BROKE OFF MID SHAFT IN THE ABDOMEN. WE WERE ABLE TO RETRIEVE IT. THEY REPORTED IT TO THEIR FAIRVIEW RECORDING SYSTEM. IT BROKE OFF IN THE MIDDLE OF THE PROCEDURE NOT DURING PLACEMENT. THEY HAD TO FISH IT OUT. THERE WAS NO PATIENT INJURY BUT THERE WAS A POST OP NOTE THAT THEY HAD TO SLIGHTLY EXTEND THE SKIN INCISION TO REMOVE THE TROCAR PIECE. OTHER OTHER THEN THAT, NO PATIENT HARM. THEY WERE USING A 5MM 0-DEGREE SCOPE AND THERE WAS NO OTHER HEAT OR ANYTHING USED WITH IT. ADDITIONAL INFORMATION PROVIDED BY AN APPLIED MEDICAL REPRESENTATIVE ON 23DEC2025: YES, BROKE INTO PATIENT AND RETRIEVED SUCCESSFULLY. I AM UNSURE ON THE DETAILS OF TROCAR INSERTION NOT USED WITH ROBOT I DO NOT BELIEVE IT WAS OUR OBTURATOR THAT WAS IN CANNULA DURING INCIDENT. INTERVENTION: OPENED UP ANOTHER PORT AND COMPLETED CASE. PATIENT STATUS: PATIENT STATUS IS OKAY. THE DATE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962283 ↗
• MalfunctionNov 7, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: TECHNICIAN NOTICED TOWARD THE END OF THE SURGERY THAT THE TROCAR HAD BROKEN, AND PIECES WERE LEFT INSIDE THE PATIENT. SURGEON WAS ABLE TO REMOVE ALL PIECES OF THE TROCAR. APPLIED MEDICAL ACCOUNT MANAGER BELIEVES IT WAS PIECES OF THE OBTURATOR OR CANNULA BUT WILL CONFIRM WITH THE NURSE OR SURGEON. PRODUCT IS NOT ABLE TO BE RETURNED AS IT WAS DISCARDED, AND NO PICTURES ARE AVAILABLE. INTERVENTION: ABLE TO REMOVE ALL PIECES OF THE TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635787 ↗
• MalfunctionSep 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: I TRIED TO CANCEL 5 BOXES OF ITEM CTF01 DUE TO A REPORTED ISSUE WITH THE PRODUCT. WE WILL NEED TO RETURN THESE BOXES ONCE THEY ARRIVE AT OUR FACILITY. I HAVE ATTACHED THE INVOICE SHOWING THE 5 BOXES IN TRANSIT. KINDLY INFORM CUSTOMER SERVICE ABOUT THE RETURN I WILL BE REQUESTING FOR THIS PRODUCT. ADDITIONAL INFORMATION PROVIDED BY APPLIED MEDICAL REPRESENTATIVE ON 18SEP2024 VIA EMAIL: I SPOKE TO THE CUSTOMER THIS MORNING AND IT SEEMS THEY WOULD LIKE TO RETURN ALL FIVE BOXES OF ITEM #CTF01 DUE TO AN ISSUE THEY HAD WITH THIS ITEM DURING SURGERY. THE CUSTOMER STATED THAT THE TROCAR BROKE INSIDE THE PATIENT DURING A PROCEDURE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340404 ↗
• MalfunctionNov 15, 2023Difficult to Insert; Difficult to Insert

  PROCEDURE PERFORMED: LAPAROSCOPIC PARTIAL GASTRECTOMY EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4). COMPLAINT 2 OF 3: (B)(4). COMPLAINT 3 OF 3: (B)(4). TWO TROCARS BROKE UPON INSERTION. ONE TROCAR WAS INSERTED WITH DIFFICULTY. [TRANSLATION]. I AM THE NEW HUS IN THE OPERATING ROOM, REPLACING [NAME]. UNFORTUNATELY, I WAS A LITTLE LATE IN REPORTING THE EVENT, BUT I WANTED TO LET YOU KNOW THAT WE HAD DIFFICULTIES WITH 2 OF YOUR CTF01 TROCARS. THE EVENTS OCCURRED ON (B)(6) 2023 WITH DR. [NAME] DURING THE SAME LAPAROSCOPIC PARIETAL GASTRECTOMY. THE PROBLEM RAISED WAS THAT THE PATIENT'S WALL WAS DIFFICULT TO PASS THROUGH AND THAT ON TWO OCCASIONS, 5 X 150 MM TROCARS WERE BROKEN AT INSERTION. A THIRD TROCAR COULD BE INSERTED WITH DIFFICULTY, BUT WITHOUT BREAKAGE. DR. [NAME] WAS THEN ASSISTED BY DR. [NAME] AND THE TWO MENTIONED TO ME THAT IT HAD NEVER HAPPENED TO THEM BEFORE. I WAS WONDERING IF THIS ISSUE HAD BEEN RAISED ELSEWHERE? THE INCIDENT DID NOT HAVE A DIRECT IMPACT ON THE PATIENT. THE LOT NUMBER OF THE TROCARS WAS 1473094 (THE SAME FOR BOTH) AND THEY WERE NOT RETAINED FOR ANALYSIS. PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 31OCT2023 VIA EMAIL FROM ACCOUN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145203 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC PARTIAL GASTRECTOMY EVENT DESCRIPTION: COMPLAINT 1 OF 3: #(B)(4). COMPLAINT 2 OF 3: #(B)(4). COMPLAINT 3 OF 3: #(B)(4). TWO TROCARS BROKE UPON INSERTION. ONE TROCAR WAS INSERTED WITH DIFFICULTY. [TRANSLATION] I AM THE NEW HUS IN THE OPERATING ROOM, REPLACING [NAME]. UNFORTUNATELY, I WAS A LITTLE LATE IN REPORTING THE EVENT, BUT I WANTED TO LET YOU KNOW THAT WE HAD DIFFICULTIES WITH 2 OF YOUR CTF01 TROCARS. THE EVENTS OCCURRED ON (B)(6) 2023 WITH DR. [NAME] DURING THE SAME LAPAROSCOPIC PARIETAL GASTRECTOMY. THE PROBLEM RAISED WAS THAT THE PATIENT'S WALL WAS DIFFICULT TO PASS THROUGH AND THAT ON TWO OCCASIONS, 5 X 150 MM TROCARS WERE BROKEN AT INSERTION. A THIRD TROCAR COULD BE INSERTED WITH DIFFICULTY, BUT WITHOUT BREAKAGE. DR. [NAME] WAS THEN ASSISTED BY DR. [NAME] AND THE TWO MENTIONED TO ME THAT IT HAD NEVER HAPPENED TO THEM BEFORE. I WAS WONDERING IF THIS ISSUE HAD BEEN RAISED ELSEWHERE? THE INCIDENT DID NOT HAVE A DIRECT IMPACT ON THE PATIENT. THE LOT NUMBER OF THE TROCARS WAS 1473094 (THE SAME FOR BOTH) AND THEY WERE NOT RETAINED FOR ANALYSIS. PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON (B)6) 2023 VIA EMAIL FROM ACC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085337 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC PARTIAL GASTRECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 3: #(B)(4). COMPLAINT 2 OF 3: #(B)(4). COMPLAINT 3 OF 3: #(B)(4). TWO TROCARS BROKE UPON INSERTION. ONE TROCAR WAS INSERTED WITH DIFFICULTY. [TRANSLATION]: I AM THE NEW HUS IN THE OPERATING ROOM, REPLACING [NAME]. UNFORTUNATELY, I WAS A LITTLE LATE IN REPORTING THE EVENT, BUT I WANTED TO LET YOU KNOW THAT WE HAD DIFFICULTIES WITH 2 OF YOUR CTF01 TROCARS. THE EVENTS OCCURRED ON (B)(6) 2023 WITH DR. [NAME] DURING THE SAME LAPAROSCOPIC PARIETAL GASTRECTOMY. THE PROBLEM RAISED WAS THAT THE PATIENT'S WALL WAS DIFFICULT TO PASS THROUGH AND THAT ON TWO OCCASIONS, 5 X 150 MM TROCARS WERE BROKEN AT INSERTION. A THIRD TROCAR COULD BE INSERTED WITH DIFFICULTY, BUT WITHOUT BREAKAGE. DR. [NAME] WAS THEN ASSISTED BY DR. [NAME] AND THE TWO MENTIONED TO ME THAT IT HAD NEVER HAPPENED TO THEM BEFORE. I WAS WONDERING IF THIS ISSUE HAD BEEN RAISED ELSEWHERE? THE INCIDENT DID NOT HAVE A DIRECT IMPACT ON THE PATIENT. THE LOT NUMBER OF THE TROCARS WAS 1473094 (THE SAME FOR BOTH) AND THEY WERE NOT RETAINED FOR ANALYSIS. PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 31OCT2023 VIA EMAIL FROM AC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085226 ↗
• MalfunctionAug 10, 2023Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY EVENT DESCRIPTION: DURING INSERTION, THE CANNULA SNAPPED IN HALF AND FELL INTO THE PATIENT. IT WAS A CLEAN BREAK THAT OCCURRED A LITTLE BELOW THE MIDPOINT OF THE CANNULA SHAFT. BOTH PIECES WERE PUT BACK TOGETHER TO DETERMINE IF THERE WAS ANY PARTICULATION, OF WHICH IT WAS DETERMINED THERE WAS NOT ANY FRAGMENTATION. THE OBTURATOR WAS INSIDE THE DEVICE AT THE TIME OF THE BREAK. THERE WAS NO PATIENT INJURY. THE CASE WAS COMPLETED WITH A NEW CTF01. PRODUCT AVAILABLE FOR RETURN. INTERVENTION: THE CASE WAS COMPLETED WITH A NEW CTF01. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499572 ↗
• InjuryJul 27, 2023Break; Break

  PROCEDURE PERFORMED: LAP BILATERAL SALPINGECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) (MFR REPORT # 2027111-2023-00533). COMPLAINT 2 OF 2: (B)(4) (MFR REPORT # 2027111-2023-00534). TWO SIMILAR EVENTS OCCURRED AT THE SAME FACILITY DURING THE SAME PROCEDURE. "WHEN TRYING TO INSERT TROCAR INTO PALMERS POINT, TROCAR FRACTURED. ANOTHER TROCAR WAS UTILIZED, AGAIN TROCAR FRACTURED INTO PIECES. BOTH TROCARS WERE UNABLE TO A THIRD TROCAR, WAS UTILIZED AND SUCCESSFULLY ENTERED THE PT. ABDOMINAL CAVITY." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 24JUL2023 FROM AN APPLIED MEDICAL REPRESENTATIVE: THE BREAK OCCURRED AT THE OBTURATOR & TIP. THE HOSPITAL WAS NOT SURE IF THERE WAS ANY DIFFICULTY NOTED DURING THE INSERTION OF THE DEVICE. THE BREAK WAS NOT CONSIDERED TO BE CLEAN AS IT WAS CRACKED/FRACTURED AND CAUSED PARTICULATION. WHEN ASKED IF ALL THE FRAGMENTS WERE RETRIEVED THE HOSPITAL STATED THEY WERE "UNABLE TO FIND WITHIN THE INCISION SIGHT." N/A NOTED FOR PATIENT INJURY AND THE PATIENT WAS DISCHARGED. THE PROCEDURE WAS A LAP BILATERAL SALPINGECTOMY. CLARIFICATION ON THE INITIAL EVENT DESCRIPTION WAS RECEIVED STATING "BOTH TROCARS WERE UNABLE TO PENETRATE THROUGH THE FASCIA SO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410188 ↗
• InjuryJul 27, 2023Break; Break

  PROCEDURE PERFORMED: LAP BILATERAL SALPINGECTOMY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) (MFR REPORT # 2027111-2023-00533). COMPLAINT 2 OF 2: (B)(4) (MFR REPORT # 2027111-2023-00534). TWO SIMILAR EVENTS OCCURRED AT THE SAME FACILITY DURING THE SAME PROCEDURE. "WHEN TRYING TO INSERT TROCAR INTO PALMERS POINT, TROCAR FRACTURED. ANOTHER TROCAR WAS UTILIZED, AGAIN TROCAR FRACTURED INTO PIECES. BOTH TROCARS WERE UNABLE TO A THIRD TROCAR, WAS UTILIZED AND SUCCESSFULLY ENTERED THE PT. ABDOMINAL CAVITY." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 24JUL2023 FROM AN APPLIED MEDICAL REPRESENTATIVE: THE BREAK OCCURRED AT THE OBTURATOR AND TIP. THE HOSPITAL WAS NOT SURE IF THERE WAS ANY DIFFICULTY NOTED DURING THE INSERTION OF THE DEVICE. THE BREAK WAS NOT CONSIDERED TO BE CLEAN AS IT WAS CRACKED/FRACTURED AND CAUSED PARTICULATION. WHEN ASKED IF ALL THE FRAGMENTS WERE RETRIEVED THE HOSPITAL STATED THEY WERE "UNABLE TO FIND WITHIN THE INCISION SIGHT." N/A NOTED FOR PATIENT INJURY AND THE PATIENT WAS DISCHARGED. THE PROCEDURE WAS A LAP BILATERAL SALPINGECTOMY. CLARIFICATION ON THE INITIAL EVENT DESCRIPTION WAS RECEIVED STATING "BOTH TROCARS WERE UNABLE TO PENETRATE THROUGH THE FASCIA S

  Patient problems: Abscess; Bacteremia; Cardiovascular Dysfunction/Insufficiency; Coma; Dizziness; Foreign Body In Patient; Ischemic Heart Disease; Necrosis; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Paralysis; Septic Shock; Thrombosis/Thrombus; Wound Infection

  MAUDE report 17410185 ↗
• MalfunctionNov 16, 2021Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY. EVENT DESCRIPTION: REP WAS NOT PRESENT IN THE CASE. PER THE SURGICAL SERVICES LEAD A TROCAR BROKE IN A PATIENT. PER THE STAFF IN THE CASE, IT IS BELIEVED TO BE THE SURGEON'S TECHNIQUE AND THE "INSERTION OF THE SCOPE THROUGH THE TROCAR WAS NOT GENTLE AS IT SHOULD HAVE BEEN." THE TROCAR HAD BEEN PLACED IN THE ABDOMEN. CAMERA WAS BEING INTRODUCED INTO THE TROCAR. PER THE TECH: DR WAS NOT AS GENTLE AS SHE HAD NOTED FROM OTHER SURGEONS AS HE INTRODUCED CAMERA DOWN TROCAR. THE TROCAR HINGED ON ONE SIDE, STILL CONNECTED ON ONE SIDE. DURING MANIPULATION OF THE TROCAR ¿ THE ENTIRE PIECE SEPARATED. PER SURGEONS OP NOTE: I ATTEMPTED TO VISUALIZE THE HEPATIC CONTOUR, BUT THE PLASTIC SLEEVE BROKE, IN THE MID LOCATION OF THE SLEEVE. THE DISTAL END WAS EASILY VISUALIZED, BUT I WAS NOT ABLE TO GRASP IT WITH THE INSTRUMENTS, IN ORDER TO REMOVE IT. THE SKIN SIDE WAS REMOVED AND THE UMBILICAL INCISION WAS EXTENDED AND THE TISSUE WAS CUT UNTIL AT THE LEVEL OF THE BREAK. THE SLEEVE WAS GRASPED WITH THE KELLY CLAMP AND IT WAS GENTLY PULLED AND REMOVED. THE TWO PIECES SEEMED TO FORM THE PREVIOUSLY INTACT SLEEVE. LARGER TROCAR WAS A CTF33 ACCOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821811 ↗
• MalfunctionSep 2, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: DURING INITIAL INSERTION FOR FIOS IN A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP OF THE OBTURATOR BROKE OFF INTO THE PATIENT. DR. [NAME] WAS THE SURGEON USING THE TROCAR. THERE WAS NO PATIENT HARM, AND THE TIP OF THE OBTURATOR WAS SEEN IN THE ABDOMEN AND RECOVERED. THE ITEM WILL BE AVAILABLE TO RETURN, AFTER IT GOES THROUGH [HOSPITAL NAME]¿S PROCESS FOR DEFECTIVE EQUIPMENT. PRODUCT RETURN EXPECTED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31AUG2021 FROM APPLIED MEDICAL ACCOUNT MANAGER: THE BREAK WAS CONSIDERED TO BE A CLEAN BREAK. IT IS UNKNOWN HOW THE CASE WAS COMPLETED AFTER THE EVENT OCCURRED. A PHOTO OF THE COMPLAINT DEVICE HAS BEEN PROVIDED. INTERVENTION: THE TIP OF THE OBTURATOR WAS SEEN IN THE ABDOMEN AND RECOVERED PATIENT STATUS: THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418435 ↗
• MalfunctionSep 24, 2019Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC TUBAL LIGATION. EVENT DESCRIPTION: THE REP. WASN'T PRESENT FOR THE CASE. STATED THAT THE TROCAR WAS ALREADY IN THE PATIENT WHEN THE CANNULA BROKE AND DIDN'T OCCUR DURING INSERTION. IT OCCURRED AT THE DISTAL END OF THE CANNULA. THE FRACTURE DID CAUSE PARTICULATION AND THE DOCTOR WAS ABLE TO RETRIEVE THE TWO PIECES FROM THE PATIENT. THE PORT WAS NOT USED WITH A ROBOT AND METHOD OF INSERTION IS CURRENTLY UNKNOWN AT THIS TIME. PER THE REP., HE STATED THAT THE SURGEON "PIECED [THE PIECES BACK] TOGETHER LIKE A PUZZLE TO MAKE SURE HE HAD ALL THE PIECES." THERE WAS NO PATIENT INJURY AND INTERVENTION IS CURRENTLY UNKNOWN AT THIS TIME. NO PHOTOS ARE AVAILABLE, BUT THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS RECEIVED FROM APPLIED MEDICAL ACCOUNT MANAGER, VIA TELEPHONE ON SEPTEMBER 26TH, 2019: THE REP. HAD A CHANCE TO SPEAK WITH THE SURGEON WHO STATED THAT IT WAS A PATIENT SPECIFIC ISSUE, I.E. THE TISSUE WAS REALLY TOUGH AND TRYING TO ACCESS THE ABDOMEN WAS DIFFICULT. THE SURGEON MANAGED TO REACH THE PERITONEUM NEAR THE FASCIA, BUT NEVER PENETRATED THE ABDOMEN. THE FRACTURE OCCURRED SOME TIME DURING THE PROCESS OF WHEN THE DOCTOR WAS TRYING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9111444 ↗
• MalfunctionSep 11, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  PROCEDURE PERFORMED: UNK. EVENT DESCRIPTION: TROCAR WAS BENT; WAS NOT USED ON PATIENT. PATIENT STATUS: NI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8998300 ↗
• MalfunctionMay 26, 2017Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER INSERTION. EVENT DESCRIPTION: 1ST CER: 2017-0802, 2ND CER: 2017-0803. DOCTOR WAS PERFORMING THIS PROCEDURE. HE TRIED TO INTRODUCE THIS PORT AS HIS PRIMARY TROCAR INSERTION. THE PATIENT HAD A THICK ABDOMINAL WALL (ESTIMATED 5 CM.). THE TROCAR GOT THROUGH THE ANTERIOR FASCIA AND OTHER LAYERS FINE BUT GOT RESISTANCE AT THE POSTERIOR FASCIA. DOCTOR CONTINUED TO TRY TO ENTER WHEN THE CANNULA AND OBTURATOR BENT IN HALF. HE TRIED A SECOND TROCAR WITH THE SAME RESULT, THEN HE BROKE SCRUB TO TRY TO FIND A DIFFERENT TROCAR OR ANOTHER SOLUTION. THE DIR. OF SURGICAL SERVICES ADVISED HIM THEY HAVE NO OTHER OPTION AND TO TRY AGAIN, WHICH HE DID AND WAS ABLE TO ENTER THE FASCIA AND PERITONEUM, AND THE PROCEDURE THEN PROCEEDED AS PLANNED. DOCTOR FEELS THIS ISSUE RESULTED IN OVER TEN MINUTES OF INCREASED PROCEDURE TIME AND "EXTRA HOLES IN THE PATIENT'S FASCIA". ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE FROM SALES REP ON MAY 3, 2017 - IT WAS DESCRIBED THAT A 10-2 MOTION AND PROPER TECHNIQUE WERE BEING USED. IT IS UNKNOWN IF THE DOCTOR BENT THE PRODUCTS MORE THE AFTER PROCEDURE. TYPE OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJ

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596110 ↗
• MalfunctionMay 26, 2017Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER INSERTION. EVENT DESCRIPTION: 1ST CER: 2017-0802, 2ND CER: 2017-0803. DR. (B)(6) WAS PERFORMING THIS PROCEDURE. HE TRIED TO INTRODUCE THIS PORT AS HIS PRIMARY TROCAR INSERTION. THE PATIENT HAD A THICK ABDOMINAL WALL (DR. (B)(6) ESTIMATED 5 CM.). THE TROCAR GOT THROUGH THE ANTERIOR FASCIA AND OTHER LAYERS FINE BUT GOT RESISTANCE AT THE POSTERIOR FASCIA. DR. (B)(6) CONTINUED TO TRY TO ENTER WHEN THE CANNULA AND OBTURATOR BENT IN HALF. HE TRIED A SECOND TROCAR WITH THE SAME RESULT, THEN HE BROKE SCRUB TO TRY TO FIND A DIFFERENT TROCAR OR ANOTHER SOLUTION. THE DIR. OF SURGICAL SERVICES ADVISED HIM THEY HAVE NO OTHER OPTION AND TO TRY AGAIN, WHICH HE DID AND WAS ABLE TO ENTER THE FASCIA AND PERITONEUM, AND THE PROCEDURE THEN PROCEEDED AS PLANNED. DR. (B)(6) FEELS THIS ISSUE RESULTED IN OVER TEN MINUTES OF INCREASED PROCEDURE TIME AND "EXTRA HOLES IN THE PATIENT'S FASCIA". ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE FROM SALES REP ON MAY 3, 2017 - IT WAS DESCRIBED THAT A 10-2 MOTION AND PROPER TECHNIQUE WERE BEING USED. IT IS UNKNOWN IF THE DOCTOR BENT THE PRODUCTS MORE THE AFTER PROCEDURE. TYPE OF INTERVENTION: NA. PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596107 ↗
• MalfunctionApr 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PROCEDURE PERFORMED UNKNOWN - "DID NOT ALLOW 5 MM SCOPE TO PASS THROUGH OBTURATOR". PATIENT STATUS: "NO PATIENT HARM".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6474303 ↗
• MalfunctionApr 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PROCEDURE PERFORMED UNKNOWN - "5 MM TROCAR WOULD ALLOW SCOPE TO PASS THROUGH 5 MM OBTURATOR." PATIENT STATUS: "NO HARM TO PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6474297 ↗
• MalfunctionMar 1, 2017Material Fragmentation; Material Fragmentation

  LAPAROSCOPIC CHOLECYSTECTOMY - "OR SURGICAL TECH TESTED 5MM TROCAR WITH 5 MM TELESCOPE. THE TELESCOPE WOULD NOT GO THROUGH. IT WAS NOTED THAT AN INTERNAL DIAPHRAGM WAS MOVING IN THE SHAFT OF THE TROCAR. THE TROCAR AND PACKAGING WAS SAVED." PATIENT STATUS - PATIENT SEEMS TO BE DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370895 ↗
• MalfunctionDec 15, 2016Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE VIA EMAIL ON JANUARY 13, 2017: THE OBTURATOR IMAGE PROVIDED BY THE CUSTOMER IS THE SAME OBTURATOR THAT WAS RETURNED TO APPLIED. THERE WAS NO DAMAGE TO THE EVENT OBTURATOR DURING OR AFTER THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6179645 ↗
• MalfunctionNov 1, 2016Break; Break

  LAPAROSCOPIC CHOLECYSTECTOMY - "DURING RE-INSERTION (PORT HAD PREVIOUSLY SLIPPED OUT) OF THE 5MM TROCAR INTO THE PATIENT, THE SHAFT OF THE TROCAR CANNULA AND OBTURATOR BEGAN TO BEND. THE TROCAR WAS THEN REPLACED FOR ANOTHER CTF01. HOWEVER, MISTAKENLY THE SURGEON PLACED THE CTF01 OBTURATOR THROUGH A CTF12 CANNULA. WHEN INSERTING THIS TROCAR THROUGH THE EXISTING DEFECT THE TIP OF THE OBTURATOR SNAPPED OFF AND REMAINED BETWEEN THE ABDOMINAL LAYERS. THE OBTURATOR TIP (ALONG WITH SEVERAL PIECES) WERE RETRIEVED FROM THE PATIENT. IN THE SAME CASE 1X CTF73' & 2X CTS22'S WERE NOT ALLOWING GAS TO BE EXPELLED THROUGH THE INSUFFLATION PORT OF THE TROCAR IN ORDER TO DESUFFLATE THE PATIENT. THE STAFF COULD NOT BE SURE WHETHER THE FAULT WAS WITH THE TROCAR, INSUFFLATION SYSTEM OR TO DO WITH PATIENT POSITIONING (AS THE PATIENT WAS HIGH BMI). THE HOSPITAL ARE NOW IN PROCESS OF TESTING THEIR INSUFFLATION SYSTEM." PATIENT STATUS: "NO PATIENT INJURY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6070319 ↗
• MalfunctionSep 14, 2016Fracture; Fracture

  LAPAROSCOPIC INSERTION OF PERITONEAL CATHETER - "A TROCAR THAT CRACKED WHILE INSERTING WITH THE OBTURATOR IN PLACE. THE ITEM # IS CTF01 LOT # 1224762 DOCTOR INSERTION OF A PERITONEAL CATHETER (LAPAROSCOPICALLY) NO HARM TO THE PATIENT. ANOTHER INSERTED AND THE CASE WAS COMPLETED." TYPE OF INTERVENTION - ANOTHER INSERTED AND THE CASE WAS COMPLETED. PATIENT STATUS - NO HARM TO THE PATIENT ADDITIONAL INFORMATION RECEIVED VIA E-MAIL FROM APPLIED MEDICAL SALES REPRESENTATIVE ON (B)(6) 2016: JUST THE SHAFT OF THE CANNULA CRACKED. THE TROCAR DID NOT BREAK OFF INTO MORE THAN ONE PIECE, IT WAS BARELY STILL ATTACHED. NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5948387 ↗
• MalfunctionJul 19, 2016Break; Break

  LAP CHOLE - "END OF CASE WHEN THE DOCTOR WAS PULLING OUT THE TROCAR, SHE PULLED IT OUT AND NOTICED THAT THE CANNULA WAS BROKEN. THE REST OF IT WAS JUTTING OUT OF THE PATIENT. SHE TOOK A HEMOSTAT AND PULLED THE REST OF THE CANNULA OUT. ONE PIECE HAD COMPLETELY SEPARATED FROM THE OTHER. CLEAN BREAK, NOTHING FELL INTO THE PATIENT. COMMENT FROM REP: "LARGER PATIENT PROBABLY A LOT OF TORQUING." PATIENT STATUS- NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5804538 ↗
• MalfunctionJan 22, 2016Break; Break

  LAPAROSCOPIC ROUX-EN-Y "SURGEON WAS PLACING TROCAR IN ABDOMEN AND TORKED JUST ENOUGH TO SNAP PLASTIC TROCAR." PATIENT STATUS- NORMAL POST OP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5387149 ↗