Premium Poly CS 015170Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521047662), received between Oct 22, 2021 and Sep 2, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL SURVEY, THE SURGEON PERFORMED AN OBSTETRIC PROCEDURE USING THE STAPLER, THERE WAS MATERNAL BLEEDING NOT REQUIRING TRANSFUSION. IT WAS NOTED THAT THE STAPLE WAS NOT ABLE TO HANDLE TISSUE THICKNESS AT TIME OF EXIT (EX UTERO INTRAPARTUM TREATMENT). THE SURGEON REPORTED THAT THE STAPLER DID NOT SUCCESSFULLY PROVIDE ADEQUATE HEMOSTASIS AND ACCESS TO THE FETUS IN AN EXIT PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22930112 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL SURVEY, THE HEALTH CARE PROFESSIONAL ENCOUNTERED MATERNAL BLEEDING (NOT REQUIRING TRANSFUSION) DIRECTLY RELATED TO THE STAPLER OR PRESENCE OF THE STAPLES TWICE IN THE LAST 12 MONTHS. THE USER DESCRIBED WHAT OCCURRED AND HOW THE PROCEDURE WAS COMPLETED FOLLOWING THE MATERNAL BLEEDING: THERE WAS ALWAYS SOME BLEEDING AT THE CORNERS THAT REQUIRES SOME ADDITIONAL SUTURES TO BE PLACED. FURTHERMORE, SURGICAL/MAJOR MEDICAL INTERVENTION THAT CHANGED THE COURSE OF PATIENT¿S CARE WAS NEVER REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22906500 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL SURVEY, THE SURGEON REPORTED THAT THE AUTO SUTURE STAPLER DID NOT SUCCESSFULLY PROVIDE ADEQUATE HEMOSTASIS IN AN OPEN IN-UTERO MYELOMENINGOCELE (MMC) REPAIR PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22788900 ↗
• MalfunctionAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL SURVEY, THE SURGEON PERFORMED AN OBSTETRIC PROCEDURE USING A STAPLER, DURING WHICH MATERNAL BLEEDING OCCURRED DIRECTLY RELATED TO THE DEVICE. NO TRANSFUSION WAS REQUIRED, AND THE REPORTER COULD NOT DESCRIBE THE EXACT INTRAOPERATIVE SEQUENCE OR HOW THE PROCEDURE WAS COMPLETED AFTER THE BLEEDING. IT WAS NOTED THAT NO SURGICAL OR MAJOR MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22786535 ↗
• MalfunctionMar 27, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN CLOSING AFTER CESAREAN SECTION, THE DEVICE CLOSED AND PARTIALLY FIRED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16618629 ↗
• MalfunctionFeb 4, 2023Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN FETAL SPINA BIFIDA SURGERY, AT UTERINE WALL INCISION OF THE CARRYING MOTHER, THE DEVICE FAILED TO CUT THROUGH UTERINE TISSUE ON FOUR TO SIX ATTEMPTS. UTERINE WALL HAD TO BE MANUALLY CUT TO RESOLVE THE ISSUE, WHICH RESULTED TO EXTENDED SURGICAL TIME BY AT LEAST THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301503 ↗
• MalfunctionMar 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN FETAL SURGERY, WHILE STAPLING THE UTERUS FOR CLOSURE, TWO STAPLERS DID NOT FIRE. TO RESOLVE THE ISSUE, THE USER OPENED A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711788 ↗
• MalfunctionOct 22, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLES DID NOT DEPLOY.

  Patient problems: Insufficient Information

  MAUDE report 12683416 ↗