PDS D9638Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031033917), received between Aug 1, 2018 and Feb 29, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A ROBOTIC COLON SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE SURGERY, THE SUTURE WAS EASILY BROKEN AT THE TIME OF WOUND CLOSURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809611 ↗
• MalfunctionOct 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE. IT WAS A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946899 ↗
• MalfunctionMar 13, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE HAD BEEN BROKEN WHEN TRYING TO USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417426 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHILE CLOSING THE WOUND BY INTERRUPTED SUTURING ON THE FASCIA, THE SUTURE BROKE DURING INSTRUMENTAL TYING. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289003 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2018 AND SUTURE WAS USED. THE SUTURE WAS BROKEN AT A KNOT DURING INTERRUPTED SUTURING ON THE FASCIA. ANOTHER NEEDLE-SUTURE WAS USED FOR THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7804944 ↗
• MalfunctionAug 1, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCDURE, THE SUTURE WAS BROKEN AT A KNOT WHILE KNOTS WERE TIED BY INTERRUPTED SUTURING ON THE FASCIA USING AN INSTRUMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739594 ↗