PDS D10105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031203334), received between Sep 13, 2022 and Dec 10, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING ANASTOMOSIS OF THE BILE DUCT AND JEJUNUM, AFTER SUTURING AT THE NODE AND WHEN LIGATION, WHEN LIGATING, THE SUTURE OF THE LIGATION WERE BROKEN AT THE NODE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891473 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON (B)(6) 2024 AND SUTURE WAS USED. DURING ANASTOMOSIS OF THE BILE DUCT AND JEJUNUM, AFTER SUTURING AT THE NODE AND WHEN LIGATION, WHEN LIGATING, THE SUTURE OF THE LIGATION WERE BROKEN AT THE NODE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891459 ↗
• MalfunctionSep 11, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS TRIED TO PULL THE NEEDLE OUT FROM THE SUTURE, BUT IT WAS DIFFICULT TO PULL OUT AND THE NEEDLE TIP WAS BROKEN. THE NEEDLE TIP FELL INTO THE ABDOMINAL CAVITY, BUT IT WAS IMMEDIATELY FOUND. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192432 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414296 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414294 ↗