NA 72200830Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010573537), received between Oct 7, 2020 and Nov 17, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Corroded” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN USING THE CANNULA SOME DEBRIS APPEARED ON CAMERA FOLLOWING THE INSERTION OF THE TROCAR AND THEN THE FLUIDS, 3 TO 4 PARTICLES OF DEBRIS WERE SEEN BRIEFLY ON CAMERA, THE SURGEON FLUSHED THE DEBRIS OUT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702939 ↗
• MalfunctionDec 30, 2020Corroded; Corroded

  IT WAS REPORTED THAT WHEN THE INNER CHAMBERS OF THE CANNULAS WERE BEING STERILIZED, IT WAS FOUND THAT THEY WERE DISCOLORED, WITH BLACK MARGINS/SCRATCHES AND CORRODED/DAMAGED AT THE TAP APERTURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095857 ↗
• MalfunctionDec 30, 2020Corroded; Corroded

  IT WAS REPORTED THAT WHEN THE INNER CHAMBERS OF THE CANNULAS WERE BEING STERILIZED, IT WAS FOUND THAT THEY WERE DISCOLORED, WITH BLACK MARGINS/SCRATCHES AND CORRODED/DAMAGED AT THE TAP APERTURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095827 ↗
• MalfunctionDec 30, 2020Corroded; Corroded

  IT WAS REPORTED THAT WHEN THE INNER CHAMBERS OF THE CANNULAS WERE BEING STERILIZED, IT WAS FOUND THAT THEY WERE DISCOLORED, WITH BLACK MARGINS/SCRATCHES AND CORRODED/DAMAGED AT THE TAP APERTURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095720 ↗
• MalfunctionOct 7, 2020Material Discolored; Problem with Sterilization; Scratched Material; Material Discolored; Problem with Sterilization; Scratched Material

  IT WAS REPORTED THAT AFTER 5 TIME OF WASHING THE CANNULA IN ORDER OF REMOVING RESIDUAL MATTER FROM THE MANUFACTURING PROCESS, THE RESIDUALS MATTER LIKE BLACK RESIDUE, SCRATCHES AND DISCOLORATIONS WERE STILL OBSERVED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10646008 ↗
• MalfunctionOct 7, 2020Material Discolored; Problem with Sterilization; Scratched Material; Material Discolored; Problem with Sterilization; Scratched Material

  IT WAS REPORTED THAT AFTER 5 TIME OF WASHING THE CANNULA IN ORDER OF REMOVING RESIDUAL MATTER FROM THE MANUFACTURING PROCESS, THE RESIDUALS MATTER LIKE BLACK RESIDUE, SCRATCHES AND DISCOLORATIONS WERE STILL OBSERVED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10645972 ↗
• MalfunctionOct 7, 2020Material Discolored; Problem with Sterilization; Scratched Material; Material Discolored; Problem with Sterilization; Scratched Material

  IT WAS REPORTED THAT AFTER 5 TIME OF WASHING THE CANNULA IN ORDER OF REMOVING RESIDUAL MATTER FROM THE MANUFACTURING PROCESS, THE RESIDUALS MATTER LIKE BLACK RESIDUE, SCRATCHES AND DISCOLORATIONS WERE STILL OBSERVED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10645896 ↗