PDS PDPB776DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031218857), received between Dec 5, 2019 and May 14, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 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.

• MalfunctionMay 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020205 ↗
• InjuryMar 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN EMERGENCY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. TWO DAYS POST-OP, AN ABDOMINAL WOUND DEHISCENCE OCCURRED. WHEN THE LAPAROTOMY WOUND WAS CHECKED, SEVERAL SUTURES WERE BROKEN WITH THE KNOT STILL REMAINING. IT WAS OPINED BY THE SURGEON THAT THE POSSIBILITY CANNOT BE RULED OUT THAT THE SUTURING TO SARCOLEMMA WAS NOT ENOUGH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21730019 ↗
• InjuryMar 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN EMERGENCY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. TWO DAYS POST-OP, AN ABDOMINAL WOUND DEHISCENCE OCCURRED. WHEN THE LAPAROTOMY WOUND WAS CHECKED, SEVERAL SUTURES WERE BROKEN WITH THE KNOT STILL REMAINING. IT WAS OPINED BY THE SURGEON THAT THE POSSIBILITY CANNOT BE RULED OUT THAT THE SUTURING TO SARCOLEMMA WAS NOT ENOUGH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21730018 ↗
• MalfunctionAug 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE IMMEDIATELY. IT WAS A CONTROL RELEASE NEEDLE. THIS HAPPENED IN SEVERAL NEEDLE-SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200120 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417831 ↗