CONVERTORS 9157Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885380164064), received between Apr 5, 2021 and Apr 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 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.

• InjuryApr 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED THE DRAPE IS THINNER IN ALL AREAS. DURING AN OPEN HEART PROCEDURE WHEN TRYING TO OPEN THE VELCRO IN THE POCKETS, THE VELCRO STAYED CLOSED AND TORE THE DRAPE. CUSTOMER STATED NON-PERFORATING INSTRUMENTS THAT SECURE TUBING TO THE DRAPE TORE THE DRAPE AND SEPARATED THE LAYERS AND THE WEIGHT OF ONE SURGICAL INSTRUMENT IS ENOUGH TO SHRED THE DRAPE; ADD ONE LINE OF TUBING AND IT WILL FALL TO THE FLOOR. THE SURGEON HAD TO USE AN ANTIBIOTIC IRRIGATION FOR THE OPEN CHEST TO HOPEFULLY PREVENT STERNAL INFECTION. CUSTOMER COULD NOT DETERMINE WHICH THEY ADMINISTERED, EITHER KEFZOL 2GM OR VANCOMYCIN 1GM. NO FURTHER ISSUE TO PATIENT WAS REPORTED POST-OP. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645731 ↗
• InjuryApr 5, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED THE DRAPE IS THINNER IN ALL AREAS. DURING AN OPEN HEART PROCEDURE WHEN TRYING TO OPEN THE VELCRO IN THE POCKETS, THE VELCRO STAYED CLOSED AND TORE THE DRAPE. CUSTOMER STATED NON-PERFORATING INSTRUMENTS THAT SECURE TUBING TO THE DRAPE TORE THE DRAPE AND SEPARATED THE LAYERS AND THE WEIGHT OF ONE SURGICAL INSTRUMENT IS ENOUGH TO SHRED THE DRAPE; ADD ONE LINE OF TUBING AND IT WILL FALL TO THE FLOOR. THE SURGEON HAD TO USE AN ANTIBIOTIC IRRIGATION FOR THE OPEN CHEST TO HOPEFULLY PREVENT STERNAL INFECTION. CUSTOMER COULD NOT DETERMINE WHICH THEY ADMINISTERED, EITHER KEFZOL 2GM OR VANCOMYCIN 1GM. NO DEMOGRAPHICS WERE PROVIDED. NO FURTHER ISSUE TO PATIENT WAS REPORTED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616433 ↗