PDS PDP800GRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031204294), received between Jun 26, 2019 and Jun 5, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY TENDON REPAIR SURGERY, ARBITRARY SKIN FLAP RECONSTRUCTION SURGERY, AND FOREIGN BODY REMOVAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT HAD BEEN ADMITTED ON (B)(6) 2024 DUE TO LEFT FOREARM PAIN AND BLEEDING FOR 2 HOURS CAUSED BY TRAUMA. THE DIAGNOSIS WAS TENDON INJURY AND AN OPEN WOUND ON THE UPPER LIMB. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL DUE TO LOCAL SWELLING AND PAIN IN THE LEFT FOREARM AFTER TRAUMA SURGERY FOR MORE THAN HALF A YEAR. THE PATIENT HAD POOR POSTOPERATIVE HEALING. ON (B)(6) 2025, A SOFT TISSUE LESION RESECTION SURGERY, TENDON RELEASE SURGERY, AND SOFT TISSUE INCISION FOREIGN BODY REMOVAL SURGERY WERE PERFORMED. DURING THE OPERATION, THE FOLLOWING WAS OBSERVED: A MASS OF ABOUT 2 BY 2 CM IN SIZE ON THE PALMAR SIDE OF THE LEFT FOREARM, CRITICAL ULCERATION OF THE EPIDERMIS, AND GREEN PATCHY FOREIGN BODY RESIDUE IN THE MASS. IT WAS OPINED THAT ONLY SUTURE WAS USED IN THE FIRST SURGERY, AND THE FOREIGN BODY MAY BE THE SUTURE WHICH HAD SLOW ABSORPTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; Pain; Skin Erosion; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 22151106 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085420 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085417 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085416 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085414 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085411 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085408 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085406 ↗
• MalfunctionAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT 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 20085392 ↗
• MalfunctionJun 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE EASILY DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736821 ↗