PDS D7190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031027350), received between Dec 4, 2018 and Dec 23, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2021Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. SEDATION WAS REQUIRED TO RESUTURE WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13072483 ↗
• MalfunctionJan 23, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS REMOVED FROM THE PACKET AND IT BROKE IN HALF. ANOTHER LIKE SUTURE WAS USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9621812 ↗
• MalfunctionJan 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND THE SUTURE WAS USED. IT WAS REPORTED WHEN PASSING THROUGH TISSUE THE SUTURE SEPARATED AT THE SWAGE. ANOTHER LIKE SUTURE WAS USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619633 ↗
• MalfunctionJan 9, 2019Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED A PATIENT UNDERWENT AN OPEN HERNIA REPAIR ON AN UNKNOWN DATE AND SUTURE WAS USED. THE TECH STATES THAT SURGEON MADE THE STITCH AND WAS GOING TO TIE. WAS USING HEMOSTAT ON ONE END AND HAND ON OTHER. WHEN HE THREW A KNOT AND WENT TO TIGHTEN IT DOWN THE SUTURE BROKE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8231706 ↗
• MalfunctionJan 8, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE, GOING TO TIE A KNOT, THE SUTURE SHREDDED. SUTURE REMOVED FROM TISSUE. THEN THE SUTURE PREMATURELY SEPARATED FROM NEEDLE AT SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228572 ↗
• MalfunctionDec 20, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE PREMATURELY SEPARATED FROM THE NEEDLE AT THE SWAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8184489 ↗
• MalfunctionDec 19, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE PREMATURELY SEPARATED FROM THE NEEDLE AT THE SWAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179187 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE BREAK IN THE MIDDLE WHILE TYING THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174549 ↗
• MalfunctionDec 4, 2018Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130007 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129944 ↗