PROTEXIS 2D73PM65Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885380027277), received between Mar 14, 2019 and Oct 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 16, 2019Material Puncture/Hole

  BASED ON INFORMATION RECEIVED BY THE CUSTOMER, ¿PER EMPLOYEE, AS I WAS HOLDING PRESSURE ON A GROIN WITH AN ARTERIAL AND VENOUS SHEATH IN PLACE, MY GLOVE HAD A HOLE IN IT, WHICH I DISCOVERED 10 MINUTES INTO THE HOLD. THE SITE WAS ACTIVELY BLEEDING. WHEN I REMOVED MY GLOVE, MY WHOLE HAND WAS COVERED IN THE PATIENT'S BLOOD. I HAVE A FEW SMALL CUTS AND ROUGH CUTICLES ON MY HAND." ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: SOURCE PATIENT (B)(6) ANTIBODY (B)(6). EMPLOYEE RECEIVED ROUTINE POST EXPOSURE COUNSELING. EMPLOYEE IS FINE. NO FURTHER MONITORING REQUIRED SINCE (B)(6).

  Patient problems: Exposure to Body Fluids

  MAUDE report 9198635 ↗
• MalfunctionMar 14, 2019Material Split, Cut or Torn

  PHYSICIAN COMPLAINED OF MULTIPLE GLOVE TEARS DURING A LAPAROSCOPIC TAH BSO - ONE GLOVE TORE IN MULTIPLE PIECES. SOME PIECES WERE RETRIEVED FROM THE ABDOMEN AND SOME WERE FOUND ON THE FLOOR OF THE OR. THE SURGEON DID ORDER ADDITIONAL ANTIBIOTICS. NO ADDITIONAL UPDATES AVAILABLE ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420674 ↗