Kii® Sheilded Bladed Access Sysem C0Q61Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915116149), received between Oct 21, 2016 and Aug 13, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 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.

• MalfunctionAug 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: LIMITED INFORMATION AVAILABLE AT THE TIME OF REPORT. TWO OF THE TROCARS BROKE DURING SURGERY. SURGEON USED A 12MM TROCAR TO RETRIEVE THE PIECES FROM THE PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31JUL2019 FROM MATERIAL COORD THERE WERE NO CONCOMITANT DEVICES USED WITH THE TROCARS. PATIENT LEFT THE OR STABLE - UNSURE OF CURRENT STATUS. PIECES THAT BROKE OFF OF TROCARS WERE RETRIEVED AND SURGERY WAS COMPLETED USING 12 MM TROCAR INSTEAD OF 8 MM. UNSURE WHERE THE FRACTURE OCCURRED. THE FRACTURE OCCURRED AFTER THE TROCARS WERE INSERTED IN USUAL FASHION, A SMALL ROUND PIECE OF PLASTIC FELL OUT FROM SOMEWHERE INSIDE THE TROCAR INTO THE PATIENT ABDOMEN. THE FRACTURE DID NOT CAUSE PARTICULATION. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PORT WAS AN ANCILLARY PORT FOR LAPAROSCOPY. PORT WAS INSERTED THROUGH THE ABDOMEN FOLLOWING INSUFFLATION TO ALLOW FOR INSERTION OF INSTRUMENTS DURING LAPAROSCOPY. THERE ARE PHOTOS AVAILABLE THAT SHOW THE BREAK. INTERVENTION: USED A 12MM TROCAR TO RETRIEVE PIECES FROM PATIENT. PATIENT STATUS: PATIENT LEFT THE OR STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889324 ↗
• MalfunctionAug 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: HYSTERECTOMY. EVENT DESCRIPTION: LIMITED INFORMATION AVAILABLE AT THE TIME OF REPORT. TWO OF THE TROCARS BROKE DURING SURGERY. SURGEON USED A 12MM TROCAR TO RETRIEVE THE PIECES FROM THE PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31JUL2019 FROM MATERIAL COORD THERE WERE NO CONCOMITANT DEVICES USED WITH THE TROCARS. PATIENT LEFT THE OR STABLE - UNSURE OF CURRENT STATUS. PIECES THAT BROKE OFF OF TROCARS WERE RETRIEVED AND SURGERY WAS COMPLETED USING 12 MM TROCAR INSTEAD OF 8 MM. UNSURE WHERE THE FRACTURE OCCURRED. THE FRACTURE OCCURRED AFTER THE TROCARS WERE INSERTED IN USUAL FASHION, A SMALL ROUND PIECE OF PLASTIC FELL OUT FROM SOMEWHERE INSIDE THE TROCAR INTO THE PATIENT ABDOMEN. THE FRACTURE DID NOT CAUSE PARTICULATION. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PORT WAS AN ANCILLARY PORT FOR LAPAROSCOPY. PORT WAS INSERTED THROUGH THE ABDOMEN FOLLOWING INSUFFLATION TO ALLOW FOR INSERTION OF INSTRUMENTS DURING LAPAROSCOPY. THERE ARE PHOTOS AVAILABLE THAT SHOW THE BREAK. INTERVENTION: USED A 12MM TROCAR TO RETRIEVE PIECES FROM PATIENT. PATIENT STATUS: PATIENT LEFT THE OR STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889319 ↗
• MalfunctionOct 21, 2016Physical Resistance; Physical Resistance

  PROCEDURE PERFORMED: UNKNOWN - "WHEN THE SCRUB ATTEMPTED TO INSERT OBTURATOR INTO CANNULA, IT WOULD NOT FIT. THAT IS WHEN THEY DISCOVERED THE PLASTIC PIECE FOR THE BLADE SHIELD HAD POPPED OUT. DR. (B)(6) WAS THE SURGEON." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM (B)(6) ON SEPTEMBER 22, 2016 - "THE TROCAR HAD NO CONTACT WITH THE PATIENT, BECAUSE THEY WERE NEVER ABLE TO PUT THE TROCAR TOGETHER". SEE ATTACHING PICTURES FOR EXPLANATION OF MALFUNCTION. "I WAS TOLD BY THE MATERIALS MANAGER THAT THE SCRUB TECH WAS GETTING THE PRODUCTS READY FOR THE CASE AND WHEN SHE WENT TO INSERT THE OBTURATOR INTO THE CANNULA IT WOULD NOT FIT. THAT IS WHEN THEY NOTICED THAT PLASTIC PIECE HAD PARTIALLY POPPED OUT. THAT IS ALL SHE COULD TELL ME." PATIENT STATUS - NO CONTACT WITH PATIENT. TYPE OF INTERVENTION - NA.

  Patient problems: No Patient Involvement

  MAUDE report 6049249 ↗