Kii Optical Access System CFR71Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915123031), received between Nov 28, 2016 and Jan 4, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Fracture; Fracture

  PROCEDURE PERFORMED: COLON OP. EVENT DESCRIPTION: WHEN INSERTING THE TROCAR, THE PATIENT'S RESISTANCE WAS SO STRONG THAT THE OBTURATOR BROKE OFF. NO FOREIGN BODY OR BONE WAS TOUCHED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 3NOV22: THE PATIENT IS FINE. CONVERTED THE SURGERY FROM LAPAROSCOPIC TO OPEN, WHICH WOULD HAVE BEEN NECESSARY EVEN WITHOUT THE PROLAPSE OF THE TROCARS. AT THAT TIME, NO OTHER INSTRUMENTS WERE USED. THE TROCARS WERE ROTATED AND INSERTED AT AN ANGEL (45°). THE TROCARS WERE NOT USED WITH A ROBOT. NO CANNULAS WERE INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. NO PIECES FELL INTO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 4NOV22: THE OPERATION SHOULD HAVE BEEN CONVERTED EVEN WITHOUT THE DAMAGE TO THE TROCARS. THE REASON THEY HAD TO CONVERT THE SURGERY FROM LAPAROSCOPIC TO OPEN WAS THAT THE ADHESIONS WERE TOO MUCH. THE PATIENT HAD A PREVIOUS SURGERY IN THIS AREA. THERE WAS CARTILAGE OR SCAR TISSUE UNDERNEATH THE INSERTION AREA. INTERVENTION: CONVERTED THE SURGERY FROM LAPAROSCOPIC TO OPEN, WHICH WOULD HAVE BEEN NECESSARY EVEN WITHOUT THE PROLAPSE OF THE TROCARS. PATIENT STATU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096470 ↗
• MalfunctionNov 9, 2022Fracture; Fracture

  PROCEDURE PERFORMED: COLON OP. EVENT DESCRIPTION: WHEN INSERTING THE TROCAR, THE PATIENT'S RESISTANCE WAS SO STRONG THAT THE OBTURATOR TIP WAS BENT. NO FOREIGN BODY OR BONE WAS TOUCHED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 3NOV22: THE PATIENT IS FINE. CONVERTED THE SURGERY FROM LAPAROSCOPIC TO OPEN, WHICH WOULD HAVE BEEN NECESSARY EVEN WITHOUT THE PROLAPSE OF THE TROCARS. AT THAT TIME, NO OTHER INSTRUMENTS WERE USED. THE TROCARS WERE ROTATED AND INSERTED AT AN ANGEL (45°). THE TROCARS WERE NOT USED WITH A ROBOT. NO CANNULAS WERE INSERTED USING THE OBTURATOR PRIOR TO THE INCIDENT. NO PIECES FELL INTO THE PATIENT. THE FOURTH TROCAR IS A CFF33, IT WAS NOT DAMAGED AND IS NOT AFFECTED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 4NOV22: THE OPERATION SHOULD HAVE BEEN CONVERTED EVEN WITHOUT THE DAMAGE TO THE TROCARS. THE REASON THEY HAD TO CONVERT THE SURGERY FROM LAPAROSCOPIC TO OPEN WAS THAT THE ADHESIONS WERE TOO MUCH. THE PATIENT HAD A PREVIOUS SURGERY IN THIS AREA. THERE WAS CARTILAGE OR SCAR TISSUE UNDERNEATH THE INSERTION AREA THE FOURTH TROCAR IS NOT RETURNING. INTERVENTION: CONVERTED THE SURGERY FROM LAPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765089 ↗
• MalfunctionJul 1, 2021Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY. . EVENT DESCRIPTION: INDICATION ENDED POSITIVELY. NO REMAINS OF THE TROCAR IN THE ABDOMEN. ACCORDING TO THE USER, THIS HAPPENED BECAUSE THE DISSECTOR GOT CAUGHT ON THE LOWER END OF THE TROCAR WHEN IT WAS REMOVED. THE DAMAGED TROCAR WAS DISPOSED OF IN THE CLINIC AFTER THE OPERATION. INTERVENTION: FRAGMENT WAS RETRIEVED. PATIENT STATUS: INDICATION ENDED POSITIVELY. NO REMAINS OF THE TROCAR IN THE ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104301 ↗
• MalfunctionOct 8, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE TROCAR BROKE WHILE IN THE PATIENT WHILE CONNECTED TO THE ROBOT AS THE CAMERA PORT. 1 PIECE BROKE OFF IN THE PATIENT. IT WAS RETRIEVED AND NO PATIENT INJURY OCCURRED. IT BROKE ON REMOVAL. IT WAS THE CANNULA THAT BROKE. UNKNOWN IF IT WAS A TIP BREAKAGE. THE CASE WAS FINISHED AT THIS TIME SO NO REPLACEMENT WAS NECESSARY. TYPE OF INTERVENTION: THE CASE WAS FINISHED AT THIS TIME SO NO REPLACEMENT WAS NECESSARY. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945456 ↗
• MalfunctionOct 20, 2017Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC ABDOMINAL CASE. EVENT DESCRIPTION: "THE TROCAR BROKE WHILE IN PATIENT'S ABDOMEN; THE CASE WAS CONVERTED TO OPEN. NO INJURY OCCURRED TO PATIENT." TYPE OF INTERVENTION: "THE CASE WAS CONVERTED TO OPEN." PATIENT STATUS: NO PATIENT INJURY OR ILLNESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6966895 ↗
• MalfunctionOct 6, 2017Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: DAVINCI LAPAROSCOPIC HYSTERECTOMY. EVENT DESCRIPTION: "DR [NAME] WAS DOING THE PROCEDURE WHEN THE BROKEN PIECE OF THE TROCAR CAP SEAL WAS DISCOVERED RESTING ON THE PATIENTS OMENTUM. THIS WAS A PIECE OF THE CAP SEAL THAT TORE." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE CUSTOMER ON (B)(6) 2017 AT 7:13 AM: DEVICE WAS THROWN AWAY AFTER USE. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE INNER SEAL, BLACK RUBBER-LIKE PIECE DETACHED. IT WAS SHAPED LIKE A CRESCENT. APPEARED TO BE TORN OFF. THE COLOR OF THE COMPONENT WAS BLACK, IT APPEARED TORN. NOT SURE WHAT INSTRUMENTATION WAS BEING USED AT THE TIME IT TORE. WE FOUND THE PIECE AFTER WORKING NEAR THE UTERUS AND SCANNED CAMERA TOWARDS SMALL BOWEL, WHERE THE PIECE WAS FOUND RESTING ON THE BOWEL. DEVICES USED IN THAT TROCAR INCLUDE SUCTION, GRASPERS, AND SPOON/SCOOP. "NO PATIENT INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6921235 ↗
• MalfunctionNov 28, 2016Break; Break

  ROBOTIC SACROLPOPEXY WITH MESH AND MID-URETHRAL SLING -- "THE TROCAR IN QUESTION FRACTURED AND BROKE NEAR THE DISTAL END OF THE CANNULA, DISTAL TO THE BALLOON. THE FRACTURED PIECE FELL INSIDE THE PATIENT'S ABDOMINAL CAVITY DURING SURGERY (UNKNOWN AT WHAT POINT THIS HAPPENED). THEY LOOKED AT THE TROCAR WITH TA LAPAROSCOPE AND REALIZED THE PIECE WAS GONE, AT WHICH POINT THEY SEARCHED FOR, DISCOVERED, AND RETRIEVED THE BROKEN PIECE. WHEN IT WAS DISCOVERED THAT THE PIECE WAS GONE TOWARD THE END OF THE CASE, IT TOOK APPROXIMATELY 3-5 MINUTES TO LOCATE THE PIECE AND ANOTHER 8-10 TO RETRIEVE IT ACCORDING TO STAFF. THE TROCAR WAS BEING USED A LAPAROSCOPE PORT FOR THE ROBOT AT THE TIME, IN THE USUAL FASHION. NO OTHER APPLIED PRODUCTS WERE BEING USED. STANDARD ROBOTIC INSTRUMENTATION WAS BEING IN THE OTHER PORTS." "AS STATED, NEITHER THE STAFF NOR THE SURGEON HAS ANY IDEA WHAT CAUSED THE TROCAR TO FRACTURE OR AT WHAT POINT IT HAPPENED. THEY ONLY DISCOVERED IT TOWARD THE END OF THE CASE. BUT THE PATIENT WAS NOT HARMED AND THE PIECE WAS SUCCESSFULLY RETRIEVED. I WAS UNSUCCESSFUL IN MEETING WITH [THE SURGEON], SO ALL INFORMATION CAME FROM THE STAFF, EITHER AS TOLD TO THEM BY [THE SURGEON], OR B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6130291 ↗