C6 3-0 Ch Gut 27"/70cm 560BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782009213), received between Jan 19, 2022 and Feb 23, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2023Break

  THE NEEDLE IS PULLING APART FROM THE SUTURE, AND IT SEEMS TO HAPPEN MOST WHEN IT IS BEING PULLED THROUGH TISSUE. WE HAVE NOT TAKEN PHOTOS AS ON ONE OR MORE OCCASIONS, THE NEEDLE NEEDED TO BE EMERGENTLY SUCTIONED FOR RETRIEVAL. NO INJURIES TO REPORT AS WE ARE JUDICIOUS IN OUR PRACTICE AND USE PRECAUTIONS LIKE THROAT PACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16425576 ↗
• MalfunctionJan 19, 2022Break

  SUTURES ARE SHREDDING AND BREAKING AND ALSO SEPARATING AT THE NEEDLE. WE WERE DOING ORAL SURGERY, DURING ALL THE INCIDENTS. ONLY ONE MAJOR PATIENT INCIDENT WHERE A NEEDLE WAS LOST IN THE PATIENT'S CHEEK, WE WERE ABLE TO REMOVE IT 24 HOURS LATER WITH ANOTHER SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13288824 ↗