Kii® OPTICAL ACCESS SYSTEM CTR72Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915125059), received between Jul 27, 2016 and Mar 23, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: TRANSLATION: FOR SOME TIME, DIFFICULTY INTRODUCING INSTRUMENTS INTO THE DEVICE. NOTED BY SEVERAL MEMBERS OF THE OPERATING TEAM. ADDITIONAL INFORMATION RECEIVED BY PHONE FROM APPLIED MEDICAL REPRESENTATIVE ON 11MAR22: NAME OF PROCEDURE BEING PERFORMED: UNKNOWN. PATIENT STATUS : NO CONSEQUENCE ON PATIENT. INSTRUMENTATION THAT WAS BEING USED AT THE TIME OF THE INCIDENT IS UNKNOWN THE EVENT UNIT HAS NOT BEEN KEPT FOR EXPERTISE, HOWEVER A REPRESENTATIVE UNIT OF THE SAME LOT WILL BE RETURNED. IT IS UNKNOWN WHAT THE USER DID AFTER EXPERIENCING THE INCIDENT. IT IS UNKNOWN HOW MANY TIMES THIS HAS BEEN OBSERVED. THE USER OBSERVED INCONSISTENT RESISTANCE DURING INSTRUMENT MANIPULATION. PATIENT STATUS: NO CONSEQUENCE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13864457 ↗
• MalfunctionJun 26, 2017Break; Break

  PROCEDURE PERFORMED: SLEEVE GASTRECTOMY. EVENT DESCRIPTION: THE TROCAR BROKE INSIDE THE WALL. ORIGINAL: LE TROCART D/2EME C'EST CASSÉ DANS LA PAROI. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP VIA EMAIL ON 13 JUNE 2017 AT 11:54AM: THE COMPLETE DEVICE IS AVAILABLE FOR EVALUATION. THE CANNULA IS BROKEN IN 2. THE BREAKAGE IS IN THE MIDDLE OF THE CANNULA, ON THE THREAD. THE SURGEON INTRODUCED A 5MM INSTRUMENT (PROBABLY A GRASPER BUT HE IS NOT SURE). HE WANTED TO GUIDE THE INSTRUMENT WHERE HE WANTED WORK. PERHAP'S THE CANNULA WAS NOT WELL ORIENTED. AND HE SAW THAT THE CANNULA WAS BROKEN APPROXIMATIVELY IN THE MIDDLE OF THE SURGERY. IT WAS A CLEAN BREAK. THE PORT WAS NOT USED WITH A ROBOT. THE METHOD OF INSERTION WAS CLASSIC INSERTION, IT'S NOT THE FIRST TROCART, SO HE CAN SEE TROCART DURING INTRODUCTION. THE 2 BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: THE PATIENT IS GOOD NOW, THE INCIDENT HAS NO IMPACT ON THE PATIENT STATUS DURING OR AFTER THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6668907 ↗
• MalfunctionJul 27, 2016Material Fragmentation; Material Fragmentation

  PARTIAL GASTRECTOMY- "USE OF OBTURATOR 12 X 150 MM. DEFECT ON THE SEAL TIGHTNESS REFLUX: TEAR AND SMALL PIECES DETACHED FROM THE DM. WE FOUND THEM INSIDE THE PATIENT ABDOMEN. APPARENTLY THIS IS NOT THE FIRST TIME. THERE WAS NO LOSS OF PNEUMOPERITONEUM. DEVICE NOT AVAILABLE FOR EVALUATION. NO PICTURES AVAILABLE." ADDITIONAL INFORMATION RECEIVED 13 JULY 2016: INSTRUMENTS USED DURING SURGERY AND BEFORE INCIDENT WERE GRASPER (REUSABLE) AND LIGASURE 5X44. MOREOVER, THE SURGEON HAS INTRODUCED A COMPRESS INSIDE ABDOMEN. TYPE OF INTERVENTION: "SURGEON HAS REMOVED THE SMALL PIECES SUCCESSFULLY FROM THE ABDOMEN. SMALL PIECES ARE BLACK COLOR. SURGEON USED ANOTHER DEVICE TO CONTINUE THE PROCEDURE." PATIENT STATUS: "OK"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5828230 ↗