PDS PDPB765DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031218901), received between Oct 25, 2019 and Dec 12, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR WOUND CLOSURE OF THE FASCIA. A WOUND SEPARATION OCCURRED AT THE ABDOMINAL WALL ABOUT 2 MONTHS AFTER THE SURGERY AND THE INTESTINE CAME OUT. THE OPINION OF THE SURGEON IS THAT THE WOUND SEPARATION IS PROBABLY CAUSED BY THE PATIENT'S FACTOR, AND NOT BY THE SUTURE PROBLEM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20915474 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURES WERE DRAWN FROM THE PACKAGE, THE LENGTH OF THE FIRST SUTURE WAS HALF OF USUAL. WHEN THE SECOND SUTURE WAS TRIED TO USE, THE SUTURE WAS DETACHED FROM THE NEEDLE EVEN THOUGH THE FORCE WAS NOT APPLIED MUCH. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084784 ↗
• MalfunctionSep 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING INTERRUPTED SUTURE. 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 17791479 ↗
• MalfunctionSep 1, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669873 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565987 ↗
• MalfunctionNov 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOW ANTERIOR RESECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE 6TH AND 7TH NEEDLES WERE HELD, THE NEEDLES BECAME DETACHED FROM THE SUTURE EASILY. THESE WERE CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799479 ↗
• MalfunctionNov 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOW ANTERIOR RESECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE 6TH AND 7TH NEEDLES WERE HELD, THE NEEDLES BECAME DETACHED FROM THE SUTURE EASILY. THESE WERE CONTROL RELEASE NEEDLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799468 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPICALLY ASSISTED DISTAL GASTRECTOMY ON (B)(6) 2020, AND THE SUTURE WAS USED FOR CLOSURE OF THE SMALL INCISION ON THE FASCIA. A MONTH AFTER THE SURGERY, REDDENING OCCURRED ON THE SITE WHERE THE SUTURE HAD BEEN USED. THEN, A DEBRIDEMENT SURGERY WAS PERFORMED UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT SUTURES THAT COULD BE REMOVED WERE REMOVED. A MONTH AFTER THAT, REDDENING OCCURRED AGAIN. AFTER THE SURGERY, IT BECAME AWARE THAT THE PATIENT HAD SOME ALLERGIC TENDENCIES. RECURRENCE OF REDDENING IS OBSERVED CURRENTLY. THERE WAS NO INFECTION OCCURRED. THE SURGEON OPINED THAT THERE WAS CAUSAL RELATIONSHIP BETWEEN THE SYMPTOM AND THE SUTURE. SOME ALLERGIC TENDENCIES WERE OBSERVED SUCH AS ONES AGAINST ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Not Applicable

  MAUDE report 10374647 ↗
• MalfunctionOct 31, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CLOSING THE SURGICAL WOUND, SUTURE WERE DETACHED FROM THE NEEDLES MORE EASILY THAN USUAL. THEY WERE CONTROL RELEASE NEEDLES. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262023 ↗
• MalfunctionOct 31, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CLOSING THE SURGICAL WOUND, SUTURE WERE DETACHED FROM THE NEEDLES MORE EASILY THAN USUAL. THEY WERE CONTROL RELEASE NEEDLES. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262021 ↗
• MalfunctionOct 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2019. DURING SURGERY, THE SURGEON FELT THAT THE SUTURE WAS DETACHED FROM THE NEEDLE TOO EASILY DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240143 ↗