PDS D9745Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031034549), received between Dec 15, 2022 and Apr 7, 2026 — 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.

• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. THE PRODUCT WAS USED ON BILE DUCT AND JEJUNAL ANASTOMOSIS. THERE WAS NO EFFECT ON THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800260 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. THE PRODUCT WAS USED ON BILE DUCT AND JEJUNAL ANASTOMOSIS. THERE WAS NO EFFECT ON THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800240 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON 3/10/2026 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. THE PRODUCT WAS USED ON BILE DUCT AND JEJUNAL ANASTOMOSIS. THERE WAS NO EFFECT ON THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800216 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN DURING USE. THE PRODUCT WAS USED ON BILE DUCT AND JEJUNAL ANASTOMOSIS. THERE WAS NO EFFECT ON THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799862 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OTORHINOLARYNGOLOGY / HEAD AND NECK SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE NEEDLE WAS APPLIED AT MUCOUS MEMBRANE, THE SUTURE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274586 ↗
• MalfunctionDec 15, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC PANCREATICODUODENECTOMY ON (B)(6) 2022 AND SUTURE WAS USED. AFTER SUTURING INSIDE OF THE BODY, WHEN THE SURGEON TRIED TO TAKE OUT THE PRODUCT FROM THE TROCAR, IT WAS NOTICED THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE AND ONLY THE SUTURE WAS TAKEN OUT. THE DETACHED NEEDLE WAS FOUND NEAR THE SEAL OF THE TROCAR. THE OPERATION TIME WAS EXTENDED MORE THAN 30 MINUTES. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990894 ↗