Kii Low Profile Bladed Dual Pack CTB23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915126582), received between Dec 18, 2025 and Dec 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Dec 11, 2025Class IIOpen, Classified

   There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

   Z-1010-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionDec 18, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: BEFORE USING THE 5 MM DIAMETER TROCAR, THE SURGEON NOTICED THAT ITS MANDREL PROTRUDED MUCH MORE THAN USUAL FROM THE SLEEVE. THE SURGEON REFUSED TO USE IT, CONSIDERING IT DANGEROUS. ALERT FROM THE SURGEON REGARDING AN ANOMALY IN THE LENGTH OF THE LAPAROSCOPIC TROCAR MANDREL. ABNORMALLY LONG (A0201). A DIFFERENCE OF NEARLY 1 CM WAS OBSERVED COMPARED TO TWO OTHER BATCHES WITH THE SAME REFERENCE NUMBER. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA PCF ON 01DEC25: HE WASN¿T SURE WHETHER IT WAS THE SHIRT THAT WAS TOO SHORT OR THE PYRAMIDAL-POINTEDMANDREL THAT WAS TOO LONG. AFTER CHECKING, THEY FOUND THAT ONLY THE LOT NUMBER INDICATED HAD THIS ANOMALY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02DEC25: THE NURSE INITIALLY HANDED THE SURGEON A TROCAR WHICH, UPON INSPECTION BEFORE USE, WAS FOUND TO BE NON-COMPLIANT WITH THE TYPE NORMALLY USED. THE NURSE THEN PROVIDED A SECOND TROCAR, WHICH TURNED OUT TO BE IDENTICAL TO THE FIRST ONE. CONSEQUENTLY, THE TEAM SWITCHED TO A DIFFERENT BOX AND LOT NUMBER TO OBTAIN A COMPLIANT TROCAR. THE TWO NON-COMPLIANT TROCARS, ALONG WITH THE BOX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844322 ↗
• MalfunctionDec 18, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: A PROBLEM HAS BEEN REPORTED CONCERNING A 5 MM LAPAROSCOPY TROCAR COMPOSED OF TWO PARTS: THE SHARP METAL MANDREL WAS TOO LONG IN RELATION TO THE OUTLET PORT OF THE PLASTIC CANNULA, THUS MAKING THE BATCH DANGEROUS. ADDITIONAL INFORMATION RECEIVED BY AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 10DEC25: THE PRODUCT HAS NOT BEEN USED ON THE PATIENT. NO PATIENT INJURY OCCURED AS A RESULT OF THIS EVENT. HOW DID THE USER RESOLVE THE SITUATION? TAKE A NEW PRODUCT. TIMING OF THE EVENT: BEFORE THE BEGINING. QUESTIONS ABOUT BLADE EXPOSED NOT APPLICABLE FOR THIS REFERENCE. DID ANYONE (PATIENT OR STAFF) GOT INJURED? NO. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844280 ↗
• MalfunctionDec 18, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: BEFORE USING THE 5 MM DIAMETER TROCAR, THE SURGEON NOTICED THAT ITS MANDREL PROTRUDED MUCH MORE THAN USUAL FROM THE SLEEVE. THE SURGEON REFUSED TO USE IT, CONSIDERING IT DANGEROUS. ALERT FROM THE SURGEON REGARDING AN ANOMALY IN THE LENGTH OF THE LAPAROSCOPIC TROCAR MANDREL. ABNORMALLY LONG (A0201). A DIFFERENCE OF NEARLY 1 CM WAS OBSERVED COMPARED TO TWO OTHER BATCHES WITH THE SAME REFERENCE NUMBER. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA PCF ON 01DEC2025: HE WASN¿T SURE WHETHER IT WAS THE SHIRT THAT WAS TOO SHORT OR THE PYRAMIDAL-POINTEDMANDREL THAT WAS TOO LONG. AFTER CHECKING, THEY FOUND THAT ONLY THE LOT NUMBER INDICATED HAD THIS ANOMALY. ADDITIONAL INFORMATION RECEIVED FROM AN APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 02DEC2025: THE NURSE INITIALLY HANDED THE SURGEON A TROCAR WHICH, UPON INSPECTION BEFORE USE, WAS FOUND TO BE NON-COMPLIANT WITH THE TYPE NORMALLY USED. THE NURSE THEN PROVIDED A SECOND TROCAR, WHICH TURNED OUT TO BE IDENTICAL TO THE FIRST ONE. CONSEQUENTLY, THE TEAM SWITCHED TO A DIFFERENT BOX AND LOT NUMBER TO OBTAIN A COMPLIANT TROCAR. THE TWO NON-COMPLIANT TROCARS, ALONG WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844237 ↗