Intuitive 5mm Cannula Seal 400161Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915119775), received between Dec 11, 2017 and Jan 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Falling” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2018Material Fragmentation; Material Fragmentation

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: THIS CER WAS CREATED FOR THE MEDWATCH RECEIVED 18 DEC 2017 VIA MAIL UNDER (B)(4). THE EVENT DATE WAS (B)(6) 2017. "A PIECE TORE OFF AND FELL INTO THE ABDOMEN. IT WAS REMOVED AND THE ENTIRE ITEM WAS REMOVED FROM THE FIELD" "THE DEVICE IS A 5 MM CANNULA SEAL FOR A DA VINCI CASE, THE SIZE OF THE PIECE THAT FELL INTO PATIENT IS APPROXIMATELY THE SIZE OF A PENCIL LED." "DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)" THIS WAS NOT A LABORATORY DEVICE OR TEST. THE PATIENT IS NOT (B)(6). ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE ON 20DEC2017 AT 9:05 AM FROM CLINICAL ENGINEER AT (B)(6) MED CTR: THE DEVICE IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: "IT WAS REMOVED AND THE ENTIRE ITEM WAS REMOVED FROM THE FIELD" PATIENT STATUS: NI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7201115 ↗
• MalfunctionDec 11, 2017Detachment Of Device Component; Component Falling

  "A PIECE TORE OFF AND FELL INTO THE ABDOMEN. IT WAS REMOVED AND THE ENTIRE ITEM WAS REMOVED FROM THE FIELD" THE DEVICE IS A 5MM CANNULA SEAL FOR A DA VINCI CASE, THE SIZE OF THE PIECE THAT FELL INTO PATIENT IS APPROXIMATELY THE SIZE OF A PENCIL LED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7103971 ↗