Kii Shielded Bladed Access SystemRecalls & reported problems across all models

We found 8 models of Kii Shielded Bladed Access System by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2015 and Sep 16, 2026 — classified as 1 death, 6 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Kii Shielded Bladed Access System problems

Kii Shielded Bladed Access System models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Kii Shielded Bladed Access System CTB73

  Laparoscope, General & Plastic Surgery
  25 reports
• Kii Shielded Bladed Access System CTB71

  Laparoscope, General & Plastic Surgery
  16 reports
• Kii Shielded Bladed Access System CTB03

  Laparoscope, General & Plastic Surgery
  14 reports
• Kii Shielded Bladed Access System CTB33

  Laparoscope, General & Plastic Surgery
  13 reports
• Kii Shielded Bladed Access System CFB33

  Laparoscope, General & Plastic Surgery
  12 reports
• Kii Shielded Bladed Access System CFB73

  Laparoscope, General & Plastic Surgery
  1 death11 reports
• Kii Shielded Bladed Access System CFB03

  Laparoscope, General & Plastic Surgery
  2 reports
• Kii Shielded Bladed Access System CTB01

  Laparoscope, General & Plastic Surgery
  1 report

Recent Kii Shielded Bladed Access System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792815 ↗
• InjuryAug 7, 2026Material Deformation

  Procedure Performed:UNK.Event Description:Circumstances/Description of the incident: The trocar was deformed at the distal end (tip), which caused injury to the patient's rib upon insertion of the trocar.Clinical findings: Rib injury.Precautionary measures and actions taken: Trocar replacement.Additional information received by an Applied Medical rep via email on 28Jul2026:I didn't manage to get any information last week, I'll try again this week.Patient Status:UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50183114 ↗
• MalfunctionMay 18, 2026Fracture

  PROCEDURE PERFORMED: UNK EVENT DESCRIPTION: [TRANSLATION] AFTER 1 HOUR AND 30 MINUTES OF USE DURING A PROCEDURE, THE TROCAR BROKE IN TWO (THE SHEATH CONTAINING THE OPTICAL FIBER). IT HAD NOT BEEN HEATED, NOR HAD IT BEEN STRUCK BY ANOTHER INSTRUMENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT¿S ABDOMEN USING AN EXTRACTION BAG. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207866 ↗
• MalfunctionMar 11, 2026Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: PIECE OF TROCAR BROKE (AT THE TIP). PATIENT STATUS: NO PATIENT INJURY OR ILLNESS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569970 ↗
• InjuryDec 9, 2025Failure to Cycle; Failure to Cycle

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: DURING INSERTION, THE TROCAR DID NOT ENGAGE. IT WAS NECESSARY TO CONVERT THE PROCEDURE TO OPEN SURGERY DUE TO PERFORATION OF A LARGE BLOOD VESSEL, REQUIRING THE INTERVENTION OF THE VASCULAR TEAM. AFTER CONVERSION TO OPEN SURGERY, THE PATIENT REMAINED IN RECOVERY IN THE UTI, DUE TO BLEEDING, REQUIRING BLOOD TRANSFUSION. THE TROCAR WAS DISCARDED DUE TO CONTAMINATION. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 10FEB2026 VIA EMAIL: UNFORTUNATELY, THE HOSPITAL IS NOT RESPONDING TO MESSAGES BECAUSE WE QUESTIONED THE USE OF A PRODUCT THAT WAS ALREADY EXPIRED. ADDITIONAL INFORMATION PROVIDED BY [DISTRIBUTOR] ON 11FEB2026 VIA EMAIL: YES, THE ABDOMEN WAS INSUFFLATED AT THE TIME THE EVENT UNIT WAS INSERTED. WE DON'T HAVE KNOWLEDGE IF THEY WERE ABLE TO ACTIVATE THE DEVICE SO THE RED INDICATOR WAS SHOWING BEFORE USE. WE DON'T HAVE KNOWLEDGE IF THE SHIELD OF THE EVENT UNIT DEPLOYED UPON ENTERING ABDOMEN. ¿UTI¿ STANDS FOR ICU. INTERVENTION: CONVERTED TO OPEN SURGERY. PATIENT STATUS: AFTER CONVERSION TO OPEN SURGERY, THE PATIENT REMAINED IN RECOVERY IN THE UTI, DUE TO BLEEDING, REQUIRING BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23759998 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPY. EVENT DESCRIPTION: INFORMATION PROVIDED BY THE FACILITY ON 17JUL2025: PART OF THIS TROCAR FELL IN THE ABDOMINAL CAVITY WHILE PERFORMING GYNECOLOGY LAPAROSCOPIC CASE (CLEAR PLASTIC PIECE). IT WAS JUST INCIDENTAL THAT WE NOTICED DURING THE SURGERY THAT THE PLASTIC PIECE FLOATING IN THE ABDOMINAL CAVITY. WE HAVE TO OPEN SECOND TROCAR TO CONFIRM THAT IT CAME FROM THE KII 10MM TROCAR THAT IS IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY ON 22JUL2025: LAPAROSCOPIC PORT. OBSERVED PLASTIC RING IN THE ABDOMEN FROM THE PORT INSIDE THE ABDOMEN. PLACED SPONGE DOWN THE TROCAR TO CLEAN OUT THE PORT AND MUST HAVE DISLODGED AT THAT TIME AND BEEN PUSHED INTO THE ABDOMEN. THERE WAS NO CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. REMOVED PLASTIC RING FROM THE ABDOMEN. CURVED KELLY USED TO GRASP SPONGE AND PUT IT DOWN TROCAR TO CLEAN OUT THE PLASTIC INTERNAL RING. ADDITIONAL INFORMATION PROVIDED BY FACILITY ON 05AUG2025: YES PIECES FELL INTO THE PATIENT. IT WAS DISASSEMBLED TO MATCH UP WITH A SECOND ONE THAT WAS USED AS A REFERENCE, MAKING SURE THAT ALL THE PIECES WAS RETRIEVED FROM THE AT THAT TIME. YES INSTRUMENTATION PASSED THROUGH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681776 ↗
• MalfunctionJul 22, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: TOTAL LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: (NAME REDACTED) WAS THE OPERATING SURGEON, PERFORMING A TOTAL LAPAROSCOPIC HYSTERECTOMY. (NAME REDACTED) REPORTED THAT IS WAS A COMPLEX CASE WITH A NUMBER OF ADHESIONS. THE TROCAR WAS POSITIONED IN THE SUPRA PUBIC REGION. (NAME REDACTED) USED A LAPAROSCOPIC RETRIEVAL BAG TO REMOVE THE OVARIES. (NAME REDACTED) REMOVED THE TROCAR TO EXTRACT THE OVARIES, AND THEN REPLACED THE TROCAR IN THE SAME INCISION TO CONTINUE THE PROCEDURE. A COLORECTAL CONSULTANT SUPPORTED THE CASE, DUE TO BOWEL ADHESIONS. I HAVE ASKED FOR THE NAME OF THE COLORECTAL SURGEON AND WILL REPORT BACK. TOWARDS THE END OF THE CASE, (NAME REDACTED) WAS MAKING A FINAL OBSERVATION OF THE ABDOMINAL AREA WITH THE SCOPE, BEFORE FINISHING THE PROCEDURE. IT WAS AT THIS POINT THAT (NAME REDACTED) NOTICED THE DAMAGE TO THE END OF THE CANNULA. (NAME REDACTED) SPENT APPROXIMATELY ONE HOUR TO LOCATE THE MISSING PIECES, AND THESE WERE FOUND IN THE DRAPES AND ON THE FLOOR. (NAME REDACTED) REPORTED THAT NO PIECES WERE LEFT IN THE PATIENT'S ABDOMEN. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 04JULY25: RETRIEVAL BAG USED: [COMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569570 ↗
• MalfunctionMar 20, 2025Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: DURING THE PROCEDURE, IT WAS OBSERVED THAT THE TROCAR WAS LEAKING. IT WAS NECESSARY TO REPLACE THE MATERIAL WITH ANOTHER. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 12NOV2024: THE PATIENT'S STATUS IS STABLE. THE EVENT WAS COMPLETED AFTER REPLACING THE TROCAR WITH ANOTHER. THE PROCEDURE BEING PERFORMED WAS A CHOLECYSTECTOMY. A VERESS NEEDLE AND AN [BRAND NAME] CLIP WERE USED WITH THE TROCAR. THE LEAK WAS NOTICED AT THE BEGINNING OF THE PROCEDURE. IS IT UNKNOWN WHAT INSTRUMENTATION PASSED THROUGH THE EVENT UNIT(S) DURING THE PROCEDURE. THERE WAS NO COMPONENT DAMAGE. INTERVENTION: IT WAS NECESSARY TO REPLACE THE MATERIAL WITH ANOTHER. PATIENT STATUS: STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658670 ↗
• MalfunctionMar 4, 2025Fracture; Fracture

  PROCEDURE PERFORMED: THORACOSCOPY ROBOT. EVENT DESCRIPTION: CUSTOMER SAYS THAT TROCAR BROKE IN THE PATIENT. ADDITIONAL INFORMATION REQUEST FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 28FEB2025: THERE WAS NO PATIENT INJURY AND THE PATIENT IS FINE. THE DEVICE WAS USED DURING THORACOSCOPY ROBOT. NO PHOTOS AVAILABLE. TROCAR PLACEMENT EVERY THING WAS GOOD BUT WHEN SURGEON WANTS TO INTRODUCE THE CAMERA HE SAW THAT THE TROCAR WAS BROKE IN TWO PIECES. INFERIOR PART OF THE TROCAR BROKE AND THE BREAK DID NOT CAUSE PARTICULATION. THE TROCAR WAS INSERTED VIA INTERCOSTAL WITH NO DIFFICULTY INSERTION. THE OBTURATOR WAS INSERTED IN THE CANNULA AT THE TIME OF THE INCIDENT. PATIENT STATUS: FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516370 ↗
• 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 ↗
• MalfunctionDec 2, 2024Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC REMOVAL OF LEFT OVARIAN CYST. EVENT DESCRIPTION: DURING REMOVAL OF SPECIMEN WITH A RETRIEVAL BAG IT WAS NOTICED ON THE SCREEN THAT THE TROCAR WAS BROKEN AT THE TIP. BITS OF THE TROCAR HAD BROKEN OFF. ONCE THE TROCAR HAD BEEN REMOVED ALL THE PIECES MADE UP THE TROCAR. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18NOV24: PATIENT STATUS IS UNKNOWN AT THE TIME OF REPORTING. THE TM STATED ' I¿M NOT SURE HOW I CAN FIND THIS OUT IF THE THEATRE STAFF DON¿T HAVE THIS ANSWER. THE HOSPITAL DID REPORT THIS FROM THEIR END AS WELL. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 20NOV24: THE TM STATED THAT THE THEATRE TEAM WERE NOT AWARE OF OR DID NOT STATE THERE WAS PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16DEC24: THE TROCAR WAS INSERTED ' WITH ROTATION WHILE IN ADVANCING IN THE CAVITY' AND THERE WAS NO DIFFICULTY DURING INSERTION. THE TROCAR WAS NOT USED WITH A ROBOT. IT WAS CONFIRMED THE ONLY INSTRUMENT THAT WAS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT WAS A SPECIMEN BAG. REGARDING PATIENT ' NO VISIBLE INJURY NOTED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20826747 ↗
• MalfunctionMar 18, 2024Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: HOSPITAL: [NAME]. PRODUCT: CTB73 12X100 KII SHIELDED BLADED ACCESS SYSTEM. "BLADES FAILED TO RETRACT PROPERLY AND LOCK." PRODUCT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM USER FACILITY VIA EMAIL ON 27FEB2024: "THE SURGERY WAS COMPLETED WITH A NEW PRODUCT FOR SAFETY REASONS. THERE WERE NO FAULTY PRODUCTS OTHER THAN THE TROCAR. THE RED INDICATOR DID NOT REMAIN EXPOSED AFTER ACTIVATION BUT BEFORE INSERTION AND THE RED INDICATOR / BLADE REMAINED EXPOSED AFTER INSERTION." INTERVENTION: THE CASE WAS COMPLETED WITH THE NEW ONE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927131 ↗
• InjuryAug 8, 2023Retraction Problem; Retraction Problem

  PROCEDURE PERFORMED: COELIOSCOPIE / LAPAROSCOPY. EVENT DESCRIPTION: [TRANSLATION] WHEN THE FIRST SINGLE-USE RETRACTABLE-BLADE TROCAR WAS INSERTED, THE BLADE APPEARED TO HAVE COME OUT OF THE TROCAR SHEATH ON ENTERING THE PERITONEUM, RESULTING IN A WOUND ON THE SMALL INTESTINE AT THE CAMERA ENTRANCE. PATIENT'S PRESENT CONDITION: IMMEDIATE LAPAROTOMY FOR DIGESTIVE SUTURE AND ABDOMINAL LAVAGE. ANTIBIOTIC PROPHYLAXIS IN PRINCIPLE. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: TROCAR WASHED. EQUIPMENT KEPT IF REQUESTED BY LAB. INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL (B)(6) 2023: THE PATIENT¿S STATUS OF HEALTH IS GOOD. HE STAYED LONGER AT THE HOSPITAL THAN PLANNED BUT NOW IT IS OK. INTERVENTION: IMMEDIATE LAPAROTOMY FOR DIGESTIVE SUTURE AND ABDOMINAL LAVAGE. ANTIBIOTIC PROPHYLAXIS IN PRINCIPLE. PATIENT STATUS: THE PATIENT¿S STATUS OF HEALTH IS GOOD. HE STAYED LONGER AT THE HOSPITAL THAN PLANNED BUT NOW IT IS OK.

  Patient problems: Laceration(s)

  MAUDE report 17484600 ↗
• MalfunctionApr 7, 2023Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: "THE FACILITY REPORTED A PIECE OF PLASTIC STUCK WITHIN THE CANULA RENDERING THE DEVICE UNUSABLE..." PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 05APR2023 VIA EMAIL FROM APPLIED MEDICAL REPRESENTATIVE: NO INJURY OCCURRED. ANOTHER CTB33 WAS USED TO COMPLETE THE CASE. THE COLOR OF THE PIECE WAS BLUE. NO PIECES FELL INTO THE PATIENT. LAPAROSCOPIC TOWER WAS BEING USED AT THE TIME OF THE INCIDENT. NO OTHER INSTRUMENTS WERE USED PRIOR TO THE INCIDENT. INTERVENTION: ANOTHER CTB33 WAS USED TO COMPLETE THE CASE. PATIENT STATUS: NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704189 ↗
• MalfunctionDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC ANTERIOR RESECTION. EVENT DESCRIPTION: HOW WAS THE DEVICE BEING USED/WHAT ACTION WAS BEING PERFORMED WHEN THE EVENT OCCURRED? INSERTING/REMOVING LAPAROSCOPIC INSTRUMENTS THROUGH PORT. FOREIGN BODY IDENTIFIED AND REMOVED UNDER VISION. NO REPLACEMENT REQUIRED AS PROCEDURE WAS FINISHING. NO OTHER PRODUCTS REQUIRED. NO PROBLEMS IDENTIFIED AT BEGINNING OF CASE - NO GAS LEAKING UNTIL THE END OF THE CASE, WHEN IT WAS DISCOVERED THAT THE SEAL WAS INSIDE THE PATIENT. THE SEAL WAS ABLE TO BE RETRIEVED FROM THE PATIENT. THE PORT DID NOT NEED TO BE REPLACED AS IT WAS THE END OF THE CASE. TYPE OF INTERVENTION: NO REQUIREMENT FOR REPLACEMENT AS PROCEDURE WAS FINISHED. PATIENT STATUS: NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999823 ↗

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