Kii® Low Profile Optical Access System CTR21Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915126476), received between May 19, 2016 and Jan 26, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  PROCEDURE PERFORMED: GYNECOLOGICAL PROCEDURE. EVENT DESCRIPTION: [TRANSLATION] ON (B)(6) 2023, IN THE GYNAECOLOGICAL SURGERY DEPARTMENT, THE TIP OF THE TROCAR BENT DURING INSERTION. ANOTHER TROCAR OF THE SAME REFERENCE WAS USED SUCCESSFULLY. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS WAS A REPETITIVE INCIDENT. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 13SEP23: THEY WILL TRY TO HAVE THE INFORMATION BUT, IT WAS IN GYNECOLOGIA. THE TIP IS FOLDED. THE TIP IS FOLDED WITHOUT PARTICULATION. JUST FOLDED. NO PIECES FELL INTO PATIENT. YES, THEY STOP THE INSERTION. NO ROBOTIC CASE. INTERVENTION: CHANGE OF DEVICE PATIENT STATUS: NO CONSEQUENCES FOR THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592231 ↗
• MalfunctionJan 26, 2024Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  PROCEDURE PERFORMED: GYNECOLOGICAL PROCEDURE. EVENT DESCRIPTION: [TRANSLATION] ON (B)(6) 2023, IN THE GYNAECOLOGICAL SURGERY DEPARTMENT, THE TIP OF THE TROCAR BENT DURING INSERTION. ANOTHER TROCAR OF THE SAME REFERENCE WAS USED SUCCESSFULLY. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS WAS AN ISOLATED INCIDENT. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL ON 13SEP23: THEY WILL TRY TO HAVE THE INFORMATION BUT IT WAS IN GYNECOLOGIA. THE TIP IS FOLDED. THE TIP IS FOLDED WITHOUT PARTICULATION. JUST FOLDED. NO PIECES FELL INTO PATIENT. YES THEY STOP THE INSERTION. NO ROBOTIC CASE. INTERVENTION: CHANGE OF DEVICE PATIENT STATUS: NO CONSEQUENCES FOR THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592221 ↗
• MalfunctionMay 19, 2016Break; Break

  THORASCOPIC EXCISION OF RIGHT PULMONARY SEQUESTRATION AND PRIMARY REPAIR OF CONGENITAL DIAPHRAGMATIC HERNIA - "APPLIED MEDICAL TROCAR #CTR21 INSERTED WITHOUT PROBLEM BUT BROKE WHEN GRASPER WAS INSERTED INTO IT FOR USE. TIP OF TROCAR BROKE OFF AND HAD TO BE RETRIEVED. ALL BROKEN PARTS WERE ACCOUNTED FOR; DR. EXAMINED AREA WITH LAPAROSCOPE AFTER INCIDENT." PATIENT STATUS - UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5668528 ↗