Kii® Low Profile Optical Dual Pack CTR24Recalls & reported problems
Applied Medical Resources Corporation · Laparoscopic Trocar Sleeve/Single Use · Class 2
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 00607915126513), received between May 16, 2023 and May 16, 2023 — 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.
MalfunctionMay 16, 2023Material Fragmentation; Material Fragmentation
PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: TIP OF CANNULAR BROKE OFF, LEAVING 2 FRAGMENTS INSIDE PATIENT WHEN REMOVED. THE SURGEON MANAGED TO SUCCESSFULLY RETRIEVE THE FRAGMENTS. PRODUCT COMPLAINT FORM: ON (B)(6) 2023: TIP OF PORT BROKE OFF IN AT LEAST TWO FRAGMENTS THAT WERE LEFT IN PATIENT AFTER PORT TAKEN OUT. SURGEON SUCCESSFULLY GATHERED BROKEN OFF FRAGMENTS BY INVESTIGATING PORT SITE. PATIENT STATUS: UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16941259 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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