Skip to content

Kii Optical Access System CFR74Recalls & reported problems

Applied Medical Resources Corporation · Trocar · Class 2

All models of Kii Optical Access System (18)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915125745), received between Apr 8, 2022 and Apr 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

Device problems

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 8, 2022Material Fragmentation; Material Fragmentation

    PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: WHEN THE TROCAR WAS USED A PORTION OF THE INSIDE OF THE TROCAR CAME OFF ON THE INSIDE OF THE TROCAR. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 30MAR2022 FROM APPLIED MEDICAL CUSTOMER RELATIONS REPRESENTATIVE: CUSTOMER FROM (B)(6) MEDICAL CENTER CALLED TO REPORT THEY COULD NOT VISUALIZE THROUGH THE TROCAR. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 01APR2022 FROM THE FACILITY: CUSTOMER CONFIRMED THERE IS ONLY ONE CFR74 LOT #1425182 COMPLAINT FROM THE FACILITY. PRODUCT WAS PICKED UP BY APPLIED FIELD TEAM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 07APR2022 FROM THE FACILITY: SURGICAL TECH REPORTS INSERTING SCOPE TO BE DIFFICULT AT TIMES. WHILE INSERTING THE SCOPE A PIECE OF THE CANNULA/INTRODUCER CHIPPED OFF AND FELL DOWN IN TO THE TIP OF THE TROCAR RESULTING IN DECREASED VIEW. REPORTED TO BE SMALL PLASTIC PIECE (BELIEVE TO BE CANNULA/INTRODUCER NOT SEAL FRAGMENT). NO INJURY TO REPORT. USED ANOTHER CFR74 TROCAR TO COMPLETE THE CASE. 10MM SCOPE WAS INSIDE OF THE CANNULA AT THE TIME OF THE INCIDENT. LOT TRACES TO 1003630. PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: USED ANOTHER CFR74 TROCAR TO COMPLETE THE CASE. PATIENT STATUS:

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14060764 ↗

Other Laparoscope, General & Plastic Surgery devices

All Laparoscope, General & Plastic Surgery devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page