Kii Shielded Bladed Access System CTB71Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00607915125066), received between Jun 13, 2016 and Jan 8, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACOSCOPY. EVENT DESCRIPTION: COMPLAINT 1 OF 2: (B)(4) (MFR # 2027111-2025-00312). COMPLAINT 2 OF 2: (B)(4) (MFR # 2027111-2025-00311). [TRANSLATION] I HAVE JUST RECEIVED A BAG FROM THE OPERATING THEATRE OF THE VISCERAL SURGERY DEPARTMENT AND IT CONTAINS (B)(4) TROCARS INCLUDING PACKAGING. IN BOTH CASES, THE ITEM IS CTB71 WITH AN IDENTICAL LOT NUMBER (1514503) AND IN BOTH CASES THE TROCAR IS BROKEN AT THE SHAFT. IT ALL HAPPENED DURING A PATIENT, I.E. AN OPERATION, AND THE SURGEON WAS MORE THAN EXPERIENCED (HEAD PHYSICIAN OF THE DEPARTMENT WITH SENIOR PHYSICIAN AS ASSISTANT). I HAVE SENT A MAKESHIFT PHOTO AND YOU CAN ROUGHLY RECOGNISE THE FRACTURE LINES. THE (B)(6) ALSO SUBMITTED AN EMAIL SUMMARIZING THE EVENTS MENTIONED BY THE HEALTHCARE USER AFTER SHE HAD COMMUNICATION WITH THE HEALTHCARE USER. SHE DID STATE THE PATIENT WAS GOOD. ADDITIONAL INFORMATION RECEIVED VIA THE CUSTOMER VIA (B)(6) LATER ON (B)(6) 2024: THE (B)(6) STATED NEW INFORMATION WAS RECEIVED, IT SEEMS THERE WERE TWO DIFFERENT TROCARS WITHIN THE SAME PRODCEDURE. THE CUSTOMER STATED THE FOLLOWING: [TRANSLATION] UNFORTUNATELY, THE WHOLE EVENT WAS A BIT MORE COMPLICATED: THERE WERE TWO DIFFERENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105398 ↗
• MalfunctionJul 15, 2019Break; Break

  PROCEDURE PERFORMED: ROBOTIC LAP CHOLE. EVENT DESCRIPTION: REP WAS NOT IN THE CASE, BUT SPOKE TO THE DOCTOR. PATIENT WAS MORBIDLY OBESE. THE TROCAR SNAPPED IN HALF WHILE IN THE PATIENT. THE STRESS/ TORQUE ON THE TROCAR SEEMED TO CAUSE THE TROCAR TO SNAP WHILE THEY WERE ATTACHING THE ROBOTIC CAMERA. THE TROCAR SNAPPED IN 2 PIECES. THEY EXTENDED THE INCISION TO REMOVE THE DISTAL HALF OF THE TROCAR AND THEN PLACED ANOTHER TROCAR TO COMPLETE THE CASE. THERE WAS NO PARTICULATION. THERE WAS NOT PATIENT INJURY. THERE ARE NO PHOTOS AVAILABLE. THE DEVICE IS AVAILABLE TO BE RETURNED. INTERVENTION: PIECES WERE RETRIEVED AND TROCAR WAS REPLACED. PATIENT STATUS: NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791724 ↗
• MalfunctionFeb 26, 2019Break; Break

  PROCEDURE PERFORMED: ROBOTIC CYSTECTOMY. EVENT DESCRIPTION: THEY COMPLETED A ROBOTIC CYSTECTOMY CASE. THEY WENT IN WITH AN APPLIED TROCAR AND THEY PUT THE 8MM ROBOTIC DAVINCI INSIDE THE APPLIED TROCAR, FOLLOWED BY THE CAMERA. WHILE LOOKING AROUND INSIDE THE PATIENT'S BODY, THEY SAW THE TROCAR CANNULA IN THE PATIENT. THEY DID NOT REALIZE THAT THE CANNULA HAD BROKE. IT WAS A CLEAN BREAK AND NO FRAGMENTS. THEY WERE ABLE TO RETRIEVE THE CANNULA PIECE FROM THE PATIENT'S BODY. THEY COMPLETED THE CASE BY USING THE [NON-APPLIED] TROCAR. THEY DID NOT HOOK UP THE ARM TO THE CANNULA AT THE TIME OF INCIDENT. THE BREAK OCCURRED ALONG THE SHAFT OF THE TROCAR. TYPE OF INTERVENTION: THEY REPLACED THE DEVICE WITH A [NON-APPLIED] TROCAR. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371224 ↗
• MalfunctionNov 29, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: ROBOT PROSTATECTOMY. INTRAOPERATIVELY, APPEARANCE OF AN INABILITY TO MOBILIZE THE ARM HOLDING THE CAMERA PROPERLY, THE SURGEON MUST EXERT ABNORMALLY STRONG PRESSURE TO PUSH THE CAMERA INTO THE PATIENT'S ABDOMEN IN ORDER TO HAVE DEEP VISIBILITY. DISCOVERY OF THE JOINT OF THE TROCAR THAT SLIDES TOGETHER WITH THE CAMERA, PREVENTING IT FROM STABILIZING. IMPOSSIBILITY OF PLACING THE CAMERA WITHOUT THE REBOUND EFFECT. ACTIONS UNDERTAKEN: CHANGE OF OBESE TROCAR 12MM X 150 REQUIRED TO CONTINUE THE PROCEDURE. HOTLINE SERVICE OF THE ROBOT HAS BEEN CALLED (ULTIMATELY NOT CONCERNED WITH THE PROBLEM). CONSEQUENCES: OTHER. IF OTHER: ELONGATION OF THE OPERATING TIME OF 15 MINUTES. TYPE OF INTERVENTION: CHANGE OF OBESE TROCAR 12MM X 150 REQUIRED TO CONTINUE THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116520 ↗
• MalfunctionDec 27, 2017Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED VIA MAIL FROM FDA, MW5075052 ON WEDNESDAY 28FEB2018"A 12X150MM CAMERA PORT MADE BY APPLIED MEDICAL: DURING THE REMOVAL OF CAMERA PORT A VALSALVA MANEUVER WAS PERFORMED AND THE PORT BROKE IN HALF. NO PIECES WERE LEFT IN THE PATIENT AND NO INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149258 ↗
• MalfunctionSep 28, 2017Break; Break

  PROCEDURE PERFORMED: DA VINCI SURGERY GYN. EVENT DESCRIPTION: "THIS DEVICE INSERT TO PATIENT'S BODY. AFTER A WHILE THE CANNULA WAS BROKEN. PLEASE CONSULT WITH ATTACHMENT." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM PURCHASING REPRESENTATIVE ON 12-SEP-2017 AT 2:39 AM. "THE FRACTURE OF THE TROCAR DID NOT CAUSE PARTICULATION." TYPE OF INTERVENTION: UNK. PATIENT STATUS: "FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6902621 ↗
• MalfunctionMay 26, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTICS HYSTERECTOMY. EVENT DESCRIPTION: THE SURGEON DOCKED THE ROBOT, PUT THE ROBOTIC CAMERA CLAMP ON THE TROCAR, AND INSERTED THE CAMERA. AS THEY WERE MOVING CAMERA AROUND, THE TROCAR CANNULA CRACKED IN HALF ABOUT 1/3 OF THE WAY UP FROM THE DISTAL END OF THE CANNULA IN A CLEAN FASHION. THIS IS THE THIRD TIME THIS HAS HAPPENED. (OTHER EVENTS ARE DOCUMENTED IN (B)(4), MEDWATCH NO. 2027111-2017-01792 AND 2027111-2017-01793). PRODUCTS MAY BE ABLE TO RETURN BUT RISK MANAGEMENT NEEDS TO HOLD ONTO PRODUCTS UNTIL THEY CAN BE RELEASED. TYPES OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596116 ↗
• MalfunctionMay 26, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTICS HYSTERECTOMY. EVENT DESCRIPTION: THIS IS THE 2ND INCIDENT THAT OCCURRED RELATING TO (B)(4) (MEDWATCH NO. 2027111-2017-01792). THE SURGEON DOCKED THE ROBOT, PUT THE ROBOTIC CAMERA CLAMP ON THE TROCAR, AND INSERTED THE CAMERA. AS THEY WERE MOVING CAMERA AROUND, THE TROCAR CANNULA CRACKED IN HALF ABOUT 1/3 OF THE WAY UP FROM THE DISTAL END OF THE CANNULA IN A CLEAN FASHION. PRODUCTS MAY BE ABLE TO RETURN BUT RISK MANAGEMENT NEEDS TO HOLD ONTO PRODUCTS UNTIL THEY CAN BE RELEASED. TYPES OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596112 ↗
• MalfunctionMay 26, 2017Break; Break

  PROCEDURE PERFORMED: ROBOTICS HYSTERECTOMY. EVENT DESCRIPTION: THE SURGEON DOCKED THE ROBOT, PUT THE ROBOTIC CAMERA CLAMP ON THE TROCAR, AND INSERTED THE CAMERA. AS THEY WERE MOVING CAMERA AROUND, THE TROCAR CANNULA CRACKED IN HALF ABOUT 1/3 OF THE WAY UP FROM THE DISTAL END OF THE CANNULA IN A CLEAN FASHION. THIS HAPPENED TWO TIMES (OTHER EVENT IS DOCUMENTED IN 2017-0816 - MEDWATCH NO. 2027111-2017-01793). PRODUCTS MAY BE ABLE TO RETURN BUT RISK MANAGEMENT NEEDS TO HOLD ONTO PRODUCTS UNTIL THEY CAN BE RELEASED. TYPES OF INTERVENTION: NA. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596111 ↗
• MalfunctionDec 28, 2016Break; Break

  BY-PASS - "THIS INCIDENT WAS REPORTED ON (B)(6) 2016 BY THE DEPARTMENT OF DIGESTIVE SURGERY OF (B)(6) HOSPITAL. INDEED, BY REMOVING THE TROCAR AT THE END OF SURGERY, THE SURGEON FOUND THAT THE DISTAL END OF THE TROCAR WAS BROKEN. A LIVER RETRACTOR WAS INTRODUCED DURING SURGERY AND WAS SUPPORTED BY AN ARTICULATED ARM, WHICH WAS SECURED TO THE OPERATING TABLE. THERE WAS NO PARTICULAR SHOCK DURING THE PROCEDURE. THE PIECE OF PLASTIC THAT DETACHED FROM THE TROCAR, FOUND IN THE ABDOMINAL CAVITY, WAS RECOVERED BY THE SURGEON. WE WILL MAKE AN OPTIONAL DECLARATION TO THE (B)(6)." ORIGINAL: "CET INCIDENT A ÉTÉ SIGNALÉ LE (B)(6) 2016 PAR LE SERVICE DE CHIRURGIE DIGESTIVE DE L'HÔPITAL DE (B)(6). EN EFFET, EN RETIRANT LE TROCART À LA FIN DE L'INTERVENTION, LE CHIRURGIEN A REPÉRÉ QUE L'EXTRÉMITÉ DISTALE DU TROCART ÉTAIT CASSÉE. UN ÉCARTEUR À FOIE A ÉTÉ INTRODUIT AU COURS DE L'INTERVENTION ET ÉTAIT SOUTENU PAR UN BRAS ARTICULÉ, LUI-MÊME FIXÉ À LA TABLE D?OPÉRATION. IL N'Y A PAS EU DE CHOC PARTICULIER PENDANT L'INTERVENTION. LE MORCEAU DE PLASTIQUE QUI S'EST DÉTACHÉ DU TROCART, RETROUVÉ DANS LA CAVITÉ ABDOMINALE, A ÉTÉ RÉCUPÉRÉ PAR LE CHIRURGIEN. NOUS ALLONS FAIRE UNE DÉCLARATION FACULTATIVE À L'

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6209602 ↗
• MalfunctionDec 13, 2016Break; Break

  ROBOTIC ASSISTED PROSTATECTOMY: "DURING THE PROCEDURE THE CANNULA IS BROKEN. THERE WAS NO UNUSUAL INSTRUMENT CHANGING". ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON NOVEMBER 16, 2016 FROM AN APPLIED MEDICAL REPRESENTATIVE: "THE SLEEVE IS BROKEN DURING THE SURGERY (DAVINCI PROSTATECTOMIE) - THE CTB71 WAS THE OPTICTROCAR. THERE WAS NO MANIPULATION - ONLY A LOW PRESSURE AND THE SLEEVES WERE BROKEN. IN THE PICTURE THE FLAW CAN BE SEEN. NO PLASTIC FRAGMENTS WERE LEFT IN THE CAVITY." A SECOND CER WILL FOLLOW FOR ANOTHER LOT WITH SAME BATCH, SECOND CER IS (B)(4). DUE TO QUALITY REASONS CUSTOMER DOES NOT WANT TO USE THE REMAINING PRODUCTS FROM THE SAME LOT. TYPE OF INTERVENTION - "N/A". PATIENT STATUS - "OK".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6172528 ↗
• MalfunctionDec 13, 2016Break; Break

  ROBOTIC ASSISTED PROSTATECTOMY - "DURING THE PROCEDURE THE CANNULA IS BROKEN. THERE WAS NO UNUSUAL INSTRUMENT CHANGING." ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM AN APPLIED MEDICAL REPRESENTATIVE ON NOVEMBER 16, 2016: I TALKED WITH THE OPERATING ROOM TEAM. THE SLEEVE IS BROKEN DURING THE SURGERY (DAVINCI PROSTATECTOMIE) - THE CTB71 WAS THE OPTICTROCAR. THERE WAS NO MANIPULATION - ONLY A LOW PRESSURE AND THE SLEEVES WERE BROKEN. AT THE PICTURE YOU CAN SEE THE FLAW. NO PLASTIC FRAGMENTS WERE LEFT IN THE CAVITY. DUE TO QUALITY REASONS CUSTOMER DOES NOT WANT TO USE THE REMAINING PRODUCTS FROM THE SAME LOT. TYPE OF INTERVENTION - "N/A". PATIENT STATUS - "OK".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6172527 ↗
• MalfunctionOct 3, 2016Bent; Fracture; Bent; Fracture

  ADDITIONAL INFO RECEIVED VIA EMAIL ON OCTOBER 12, 2016 - THE TROCAR CRACKED 2/3 OF THE WAY DOWN THE SHAFT. THE LOCATION OF THE CAMERA PORT BEING USED WAS AT THE UMBILICUS. THE TROCAR WAS INSERTED DIRECTLY ENTRY BLADED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5995583 ↗
• MalfunctionSep 13, 2016Break; Break

  BY-PASS + CHOLECYSTECTOMY - "NATURE OF INCIDENT: THE TIP OF THE TROCAR BROKE DURING THE INTERVENTION IN THE PATIENT'S ABDOMEN." ADDITIONAL INFORMATION FROM SALES REP SENT AUGUST 17, 2016: THERE IS NO INFORMATION ON HOW THE FRACTURE OCCURRED. THE SURGEON NOTICED THE FRACTURE AT THE END OF THE PROCEDURE WHEN HE WANTED TO REMOVE THE TROCAR. THE FRACTURE WAS A CLEAN BREAK AND THE PORT WAS USED AS AN ANCILLARY PORT. IT WAS A STANDARD METHOD OF INSERTION KNOWING THAT THIS IS A BLADED TROCAR. PATIENT STATUS - "PATIENT IS OK". TYPE OF INTERVENTION - "CONSEQUENCES: THE SURGEON IMMEDIATELY REMOVED THE TROCAR AND MANAGED TO RECOVER THE BROKEN TIP."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5948359 ↗
• InjurySep 9, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  ROBOTIC LAP CHOLE - REPORTED THAT A TROCAR FAILURE INJURED ILIAC ARTERY UPON INSERTION. SURGEON WAS NOT WANTING TO RELEASE MUCH INFORMATION. REP TALKED TO OR STAFF AND MENTIONED THEY HEARD AN AUDIBLE CLICK AFTER INSERTING THROUGH PERITONEUM. THEY WERE NOT ABLE TO GET MUCH INFORMATION, BUT REP USED DEVICE AFTER PROCEDURE AND SAID BLADE ACTIVATION MECHANISM SEEMED TO BE WORKING. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE ON SEPTEMBER 8, 2016: "I FIRST SWITCHED THE TOGGLE OVER TO WHERE THE WINDOW WAS SHOWING RED ON THE PROXIMAL SIDE OF THE TROCAR (SAME SIDE AS THE SEAL HOUSING). ON THE SECOND IMAGE - JUST AS I BEGAN TO APPLY PRESSURE TO THE PACKAGING, THE DEVICE MADE AN AUDIBLE 'CLICK' INDICATING THAT THE BLADE WAS ACTIVATED. ALSO, ON THE SECOND IMAGE THE SHIELD IS BEING RETRACTED AND EXPOSING THE BLADES AS I APPLY PRESSURE. AS SOON AS THE DISTAL TIP OF THE TROCAR (BLADE SIDE) PASSED THROUGH THE PACKAGING THERE WAS A SECOND AUDIBLE 'CLICK' AND THE SHIELD SLIDE BACK COVERING OVER THE BLADE BACK INTO ITS ORIGINAL POSITION." "MET WITH RISK MANAGEMENT AND THEY SPOKE WITH SOMEONE IN THE OR THAT WAS A TECH IN THE ROOM - TECH SAID THEY HEARD AN AUDIBLE CLICK AFTER BLADE WENT T

  Patient problems: Injury

  MAUDE report 5939844 ↗
• MalfunctionJun 13, 2016Break; Break

  ROBOTIC MYOMECTOMY - "TROCAR SNAPPED IN HALF WHEN THE CAMERA WAS BEING REINSERTED INTO THE CANNULA HAPPENED TOWARDS THE END OF THE CASE, ABOUT 3 HOURS IN. CLEAN BREAK AND NO PIECES FELL OFF IN TO THE PATIENT. THE CLAMP ON THE ROBOT ARM BEING USED WAS THE CLAMP FOR ETHICON TROCARS." PATIENT STATUS: OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5721486 ↗