PDS D10057Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031134324), received between Apr 16, 2018 and Mar 16, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN UNKNOWN LAPAROSCOPIC PROCEDURE, IT WAS FOUND WHEN THE PACKAGE WAS OPENED AND THE PRODUCT WAS BEING USED IN THE OPERATING ROOM THAT THE SUTURE AND THE NEEDLE HAD BEEN DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604687 ↗
• MalfunctionFeb 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL MASTECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. AFTER OPENING THE PACKAGE BEFORE USE, A SCRUB NURSE REALIZED THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS A CONTROL RELEASE NEEDLE. THE COMPLAINT PRODUCT WAS NOT USED AND THE REMAINING 3 NEEDLE-SUTURES FROM THE SAME PACKAGE WERE USED FOR DERMAL SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294412 ↗
• MalfunctionOct 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TWO NEEDLES IMMEDIATELY DETACHED FROM TWO SUTURES AND THESE WERE NOT USED FOR THE SURGERY. THESE WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705425 ↗
• MalfunctionOct 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TWO NEEDLES IMMEDIATELY DETACHED FROM TWO SUTURES AND THESE WERE NOT USED FOR THE SURGERY. THESE WERE CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705424 ↗
• MalfunctionJul 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213163 ↗
• MalfunctionMay 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE UNINTENDEDLY WHEN TYING A KNOT DURING DERMOSTITCH. IT WAS A CONTROL RELEASE NEEDLE. IT WAS COMMENTED THAT THE BITING OF THE SUTURE MIGHT BE NOT ENOUGH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091631 ↗
• MalfunctionJul 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2019, AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN AFTER PASSING THE NEEDLE THROUGH THE DERMIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780849 ↗
• MalfunctionMar 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS DETACHED EASILY FROM THE SUTURE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386925 ↗
• MalfunctionApr 16, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CAESAREAN SECTION AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7433720 ↗