PDS Z774DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031061736), received between Oct 8, 2019 and Feb 25, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 25, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY FOR UTERINE CANCER ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NURSE POINTED OUT THAT THERE WAS A FOREIGN MATTER ON THE TIP OF A CONTROL RELEASE NEEDLE. THE NURSE WHO NOTICED THE FOREIGN MATTER USED ANOTHER PACKAGE, SO THERE WAS NO EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461299 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING A BREAST RECONSTRUCTION PROCEDURE THAT FOUR SUTURES BROKE ABOUT TWO INCHES FROM THE NEEDLE. NEW SUTURES WERE OPENED FROM THE SAME LOT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148873 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED,THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING A BREAST RECONSTRUCTION PROCEDURE THAT FOUR SUTURES BROKE ABOUT TWO INCHES FROM THE NEEDLE. NEW SUTURES WERE OPENED FROM THE SAME LOT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148866 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING A BREAST RECONSTRUCTION PROCEDURE THAT FOUR SUTURES BROKE ABOUT TWO INCHES FROM THE NEEDLE. NEW SUTURES WERE OPENED FROM THE SAME LOT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148841 ↗
• MalfunctionNov 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING A BREAST RECONSTRUCTION PROCEDURE THAT FOUR SUTURES BROKE ABOUT TWO INCHES FROM THE NEEDLE. NEW SUTURES WERE OPENED FROM THE SAME LOT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148840 ↗
• MalfunctionNov 9, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS J774D IN THE PACKAGE NOT Z774D. THE ACTUAL PRODUCT WAS DISCARDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759001 ↗
• MalfunctionOct 8, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING WOUND CLOSURE, WHEN PASSING A NEEDLE AT THE 1ST STITCH, THE NEEDLE TIP WAS BROKEN. THE BROKEN NEEDLE TIP FELL INSIDE THE PATIENT, BUT IT WAS FOUND AND RETRIEVED. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167791 ↗