Kii Shielded Bladed Access System CTB03Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607915123512), received between Jan 25, 2016 and Sep 26, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2022Fracture; Fracture

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: DR. [NAME] MENTIONS HE WAS ABOUT TO INTRODUCE THE 5X100MM TROCAR INTO THE CAVITY WITH THE ACTIVATION MECHANISM WINDOW IN RED AND HE WAS UNABLE TO INTRODUCE THE TROCAR, WHILE THE ACTIVATION MECHANISM BECAME DEACTIVATED, HE ACTIVATED IT AGAIN AND TRIED TO INTRODUCE THE TROCAR WITH NO SUCCESS, HE MENTIONS ON THE THIRD ATTEMPT TO INTRODUCE THE TROCAR INTO THE ABDOMINAL CAVITY THE TROCAR BENDED AND BROKE, HE THEN ASKED FOR A NEW TROCAR AND WAS ABLE TO INTRODUCE IT AND COMPLETE THE SURGERY. PRODUCT AVAILABLE TO BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED ON 12SEPT22 VIA EMAIL BY APPLIED MEDICAL REPRESENTATIVES: IN THE COMPLAINT, IT WAS THE FIRST TROCAR TO BE PLACED THROUGH THE UMBILICAL INCISION. THE BROKEN WAS NOT CONSIDERED CLEAN, SINCE THE BROKEN WAS PARTIAL, NO PARTICULATION WAS CAUSED. NOTE: IT WAS THE CANNULA THAT PARTIALLY BROKE, THE OBTURATOR WAS ONLY BENT. AND THE TROCAR THAT WILL BE SENT (THE CANNULA IS ALREADY BROKEN, IT FINISHED BREAKING AND/OR DETACHING WHEN THE TECHNICIAN WASHED IT). INTERVENTION: NEW TROCAR AND WAS ABLE TO INTRODUCE IT AND COMPLETE THE SURGERY. PATIENT STATUS: GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15485703 ↗
• MalfunctionMar 9, 2022Dull, Blunt; Dull, Blunt

  PROCEDURE PERFORMED: APPENDECTOMY. EVENT DESCRIPTION: TWO COMPLAINTS HAVE BEEN MADE FROM THIS SUBMISSION. "THE QUALITY ASSURANCE COORDINATOR DESCRIBES AS AN ACTION NOT SATISFACTORY AS FOLLOW: 'TWO TROCARS ARE OPENED FOR SURGERY, THE SURGEON, WHEN TRYING TO OCCUPY SUPPLIES, COMMENTS THAT THE FIRST TROCAR HAS NO EDGE, THE SECOND TROCAR IS DELIVERED AND REPEATS THE SAME' " PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 02MAR2022 FROM APPLIED MEDICAL REPRESENTATIVE: "CONFIRM THAT THE PATIENT HAD NO PROBLEM" ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07MAR2022 FROM APPLIED MEDICAL REPRESENTATIVE: THE COMPLAINT THE FACILITY SUBMITTED IS THAT THE BLADE WAS DULL. PATIENT STATUS: CONFIRM THAT THE PATIENT HAD NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713178 ↗
• MalfunctionMar 9, 2022Dull, Blunt; Dull, Blunt

  PROCEDURE PERFORMED: APPENDECTOMY. EVENT DESCRIPTION: TWO COMPLAINTS HAVE BEEN MADE FROM THIS SUBMISSION. THE QUALITY ASSURANCE COORDINATOR DESCRIBES AS AN ACTION NOT SATISFACTORY AS FOLLOW : 'TWO TROCARS ARE OPENED FOR SURGERY, THE SURGEON, WHEN TRYING TO OCCUPY SUPPLIES, COMMENTS THAT THE FIRST TROCAR HAS NO EDGE, THE SECOND TROCAR IS DELIVERED AND REPEATS THE SAME PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(60 2022 FROM APPLIED MEDICAL REPRESENTATIVE: CONFIRM THAT THE PATIENT HAD NO PROBLEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2022 FROM APPLIED MEDICAL REPRESENTATIVE: THE COMPLAINT THE FACILITY SUBMITTED IS THAT THE BLADE WAS DULL. PATIENT STATUS: CONFIRM THAT THE PATIENT HAD NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712882 ↗
• MalfunctionJul 1, 2021Dull, Blunt; Dull, Blunt

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: FOR THE SECOND TROCAR, THE BLADE OF THE INTRODUCER APPEARED TOO DULL TO CUT THROUGH TISSUE SAFELY TOE ENTER THE PATIENT. PACKAGING INCLUDED FOR SECOND TROCAR IN CASE THAT WAS THE ISSUE AND NOT THE INTRODUCER. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 18JUN2021 FROM [USER FACILITY]: THE BLADE DULLNESS WAS FIRST NOTED, "WHEN DR. [NAME] TRIED TO PUT IN THE SECOND TROCAR. AFTER THREE ATTEMPTS SHE ASKED FOR A NEW TROCAR AND TO DO THE NON-CONFORMING PRODUCT PAPERWORK ON THE ONE THAT APPEARED DULL. NOTE THAT IT WAS A DIFFERENT TROCAR THAN WHAT CAME WITH THE INTRODUCER." THE DULL INTRODUCER CAME FROM A DIFFERENT TROCAR THAN THE ONE THAT WAS BEING INSERTED INTO THE PATIENT AT THE TIME OF THE EVENT. THE TROCAR BEING INSERTED WAS A CTS02, THE LOT NUMBER IS UNKNOWN. THE CASE WAS COMPLETED BY USING ANOTHER CTB03. INTERVENTION: THE CASE WAS COMPLETED BY USING ANOTHER CTB03. PATIENT STATUS: PATIENT NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104250 ↗
• MalfunctionSep 2, 2020Retraction Problem; Retraction Problem

  EVENT 1 OF 2: MW # 2027111 - 2020 - 00544. EVENT 2 OF 2: MW # 2027111 - 2020 - 00545. PROCEDURE PERFORMED: ROBOTIC ASSISTED LAPAROSCOPY, LYSE OF ADHESION, RESECTION OF ENDOMETRIOSIS. EVENT DESCRIPTION: THE REP WAS NOT PRESENT DURING THE CASE. DURING THE CASE TWO CTB03 TROCARS WERE INSERTED INTO THE PATIENT ABDOMEN. WHEN THE CAMERA WAS INSERTED INTO THE ABDOMEN AND USED TO EXAMINE THE ABDOMEN, IT WAS NOTED THAT THE BLADES ON THESE TWO TROCARS WERE STILL ENGAGED AND NOT COVERED BY THE SHIELD. THE TROCARS WERE NOT REMOVED AND WERE USED TO COMPLETE THE CASE. NO PATIENT INJURY, PATIENT STATUS IS FINE. PRODUCTS ARE AVAILABLE FOR RETURN. INTERVENTION: CONTINUED TO USE THE EVENT TROCARS. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483214 ↗
• MalfunctionSep 2, 2020Retraction Problem; Retraction Problem

  EVENT 1 OF 2: MW # 2027111 - 2020 - 00544. EVENT 2 OF 2: MW # 2027111 - 2020 - 00545. PROCEDURE PERFORMED: ROBOTIC ASSISTED LAPAROSCOPY, LYSE OF ADHESION, RESECTION OF ENDOMETRIOSIS. EVENT DESCRIPTION: THE REP WAS NOT PRESENT DURING THE CASE. DURING THE CASE TWO CTB03 TROCARS WERE INSERTED INTO THE PATIENT ABDOMEN. WHEN THE CAMERA WAS INSERTED INTO THE ABDOMEN AND USED TO EXAMINE THE ABDOMEN, IT WAS NOTED THAT THE BLADES ON THESE TWO TROCARS WERE STILL ENGAGED AND NOT COVERED BY THE SHIELD. THE TROCARS WERE NOT REMOVED AND WERE USED TO COMPLETE THE CASE. NO PATIENT INJURY, PATIENT STATUS IS FINE. PRODUCTS ARE AVAILABLE FOR RETURN. INTERVENTION: CONTINUED TO USE THE EVENT TROCARS. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483036 ↗
• MalfunctionJun 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: I WAS CONTACTED BY CLINICAL LEAD ODP VIA EMAIL ON MAY 15, 2019: WE HAD AN INCIDENT ON MONDAY WITH THE 100MM Z-THREAD SLEEVE REF CTS02 THE SMALL SAFETY FEATURE PIECE CAME OFF INSIDE THE PATIENT, UNFORTUNATELY WE THE TEAM THREW THE SLEEVE AWAY AS IT HAD BEEN IN THE PATIENT AND THE WRAPPER , WE HAVE TRACED IT TO 3 POSSIBLE LOT NUMBERS 1331797, 1348167, .WE ONLY HAD THREE LEFT ON THE SHELF SO WE HAVE PULLED THESE AND THE NEW BATCH WHICH HAVE ARRIVED TODAY . ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON MAY 15, 2019: CLINICAL LEAD ODP ATTACHED A PICTURE AND MARKED THE PIECE THAT DETACHED. THERE ARE 3 POTENTIAL LOT NUMBER BUT SOMEONE PINCHED ONE OFF THE DESK- IT'S THE ONE IN THE PICTURE AND THREW THE PACKAGING AWAY. THE PROCEDURE WAS A LAP CHOLE AND THE SURGEON WAS MR (B)(6). THE PIECE IN THE ATTACHED PHOTO WENT INTO THE PATIENT. EVERYTHING WAS RETRIEVED FROM THE PATIENT. THE COMPONENT OF THE PIECE WAS CLEAR AND IT WAS COMPLETE. AS A SAFETY PRECAUTION WE HAVE PULLED THE REST OF THE STOCK FROM SHELVES. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON MAY 17, 2019: I HAVE B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667664 ↗
• MalfunctionApr 23, 2018Mechanical Jam; Mechanical Jam

  PROCEDURE PERFORMED: LAP CHOLE EVENT DESCRIPTION: THE SURGEON INITIALLY WENT IN WITH THE HASSON TECHNIQUE FOR THE FIRST PORT. THE SURGEON GOT THE CTB03 TROCAR, ACTIVATED IT AND PLACED THE TROCAR. WHEN THE SURGEON LOOKED AT THE TROCAR FROM THE FIRST PORT WITH THE CAMERA THE SURGEON OBSERVED THAT THE BLADE WAS STILL EXPOSED. THE SURGEON TOOK OUT THE OBTURATOR AND HIT IT AGAINST SOMETHING HARD TO ATTEMPT TO SEE IF THE SHIELD WOULD COVER THE BLADE; HOWEVER, IT DID NOT WORK AND THE BLADE WAS STILL EXPOSED. THE SURGEON CONTINUED TO USE THE TROCAR FOR THE 3RD PORT WITH THE BLADE STILL EXPOSED AND COMPLETED THE CASE WITHOUT FURTHER INCIDENT. NO OTHER INSTRUMENTS WERE IN USE INSIDE THE TROCAR AT THE TIME OF THE EVENT. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. THE FACILITY IS CURRENTLY UNDERGOING A TROCAR PRODUCT TRIAL. THE REP WAS NOT PRESENT FOR THE CASE. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2018 FROM ACCOUNT MANAGER: "THERE WAS NO INJURY OR ILLNESS ASSOCIATED WITH THE COMPLAINT EVENT, AND THE PATIENT STATUS IS FINE. THE TROCAR WAS REPLACED AND THE CASE PROCEEDED AS EXPECTED. I DO NOT HAVE ANY SPECIFIC PATIENT INFORMATION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7452324 ↗
• MalfunctionMar 2, 2017Material Fragmentation; Material Fragmentation

  LAP APPENDICECTOMY - "ASPIRATING OVARIAN CYST WITH LAP NEEDLE. WHEN REMOVED NEEDLE FROM PORT PART OF THE SEAL CAME OUT WITH THE NEEDLE. WHEN THE INSTRUMENT GUARD (CLEAR PLASTIC CIRCULAR FLANGE) WAS EXAMINED THERE WERE ONLY 7 SEGMENTS LEFT, TWO HAD SHEARED OFF. ONCE CAME OUT WITH NEEDLE AND HAD TO SEARCH FOR THE OTHER SEGMENT IN THE ABDOMEN. THIS WAS LOCATED AND REMOVED. AN EXTRA 5MM PORT WAS INSERTED TO FIND SEGMENT." PATIENT STATUS - FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372908 ↗
• MalfunctionMar 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PATIENT PROCEDURE UNKNOWN. "ONE TWO SEPARATE INTRA-OPERATIVE OCCASION THE SLIDING LOCK (SAFETY SHIELD) ON THE CTB03 TROCAR WOULD NOT ENGAGE. SLIDE SLIDED BACK TO NEUTRAL POSITION. TWO DEVICES DETECTED SO FAR." PATIENT STATUS: NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372199 ↗
• MalfunctionMar 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PROCEDURE PERFORMED UNKNOWN. "ONE TWO SEPARATE INTRA-OPERATIVE OCCASION THE SLIDING LOCK (SAFETY SHIELD) ON THE CTB03 TROCAR WOULD NOT ENGAGE. SLIDE SLIDED BACK TO NEUTRAL POSITION. TWO DEVICES DETECTED SO FAR." PATIENT STATUS: NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372195 ↗
• MalfunctionJul 6, 2016Retraction Problem; Retraction Problem

  FROM MEDWATCH REPORT: "LAPROSCOPIC TOTAL HYSTERECTOMY - "BLADE DIDN'T RETRACT DURING SURGERY. NO PATIENT HARM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5774018 ↗
• MalfunctionJun 9, 2016Retraction Problem; Retraction Problem

  LAP TOTAL HYSTERECTOMY - "THE BLADE WAS EXPOSED AS NORMAL AS IT PASSED THROUGH TISSUE BUT WOULD NOT RETRACT ONCE THROUGH." PATIENT STATUS - "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5709281 ↗
• MalfunctionJan 25, 2016Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED UNKNOWN. "THE SURGEON WAS USING THE TROCAR BY PUTTING AN INSTRUMENT THROUGH THE PORT AND HEARD THE TROCAR CRACK. THEY HAD TO REMOVE TROCAR AND FIND ALL PIECES IN THE PATIENT."PATIENT STATUS - "RELEASED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5390048 ↗