PDS D6659Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031026636), received between Dec 26, 2018 and Oct 23, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN TAKING OUT THE NEEDLE-SUTURE FROM THE PACKAGE AFTER HOLDING THE NEEDLE WITH A NEEDLE-HOLDER, THE NEEDLE WAS DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE EVALUATION A SHORT INSERTION WAS OBSERVED IN THE STRAND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686742 ↗
• MalfunctionOct 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN TAKING OUT THE NEEDLE-SUTURE FROM THE PACKAGE AFTER HOLDING THE NEEDLE WITH A NEEDLE-HOLDER, THE NEEDLE WAS DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING THE EVALUATION A SHORT INSERTION WAS OBSERVED IN THE STRAND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685078 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING PORT SITE CLOSURE, WHEN LIGATURING AFTER THE FIRST PASSING OF THE NEEDLE THROUGH THE TISSUE, THE SUTURE WAS BROKEN OTHER THAN THE LIGATION PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196595 ↗