PDS D7185Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031027343), received between Mar 10, 2022 and Apr 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE HAS BROKEN WHILE IN PATIENT FOR HERNIA REPAIR PATIENT HAS BEEN X-RAYED AND I'VE BEEN TOLD THIS WAS VISIBLE. SEEING SURGEON ON (B)(6) TO GET MORE INFORMATION AS THIS WAS RELAYED TOME FROM A NURSE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844464 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE BROKE OFF FROM SUTURE INTO PATIENT WHEN SECURING PORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24669868 ↗
• MalfunctionJul 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 0 PDS ATRAUMATIC WAS DETACHED & STUCK INSIDE PATIENT¿S CAVITY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413983 ↗
• MalfunctionJul 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC DISTAL PANCREATECTOMY AND SPLENECTOMY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE OFF FROM THE ATRAUMATIC NEEDLE AND WAS STUCK INSIDE PATIENT¿S CAVITY. THE SURGEON MANAGED TO TAKE IT OUT AT THE END. THE SUTURE ONLY PASSED THROUGH SOFT TISSUE TWICE AND DETACHED WHEN SURGEON WAS PULLING GENTLY ON IT TO TIE OFF: THERE WERE NO KNOWN COMPLICATION AS A RESULT OF THE PROLONGED SURGERY TIME UP-TO-DATE. THE TISSUE BEING SUTURED WAS LODGED BETWEEN LAYERS OF FAT. NO ADDITIONAL DISSECTION WAS REQUIRED ON OTHER TISSUE OTHER THAN TARGETED TISSUE, ALTHOUGH SURGEON HAD TO USE A PAIR OF ARTERY TO DIG THROUGH THE FAT TO LOOK FOR AND RETRIEVE THE NEEDLE. THE OPERATION WAS PROLONGED BECAUSE OF IT. THERE IS NO RECORD OF THE EXACT MINUTE COUNT. THERE WAS NO KNOWN CHANGE IN POST OP CARE RELATED TO THE PROLONGED OPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17373452 ↗
• MalfunctionMar 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE CAME AWAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13723685 ↗