PDS Z594GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031061477), received between Jan 16, 2019 and Aug 2, 2022 — classified as 1 injury, 5 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN DURING USE. THE BROKEN NEEDLE DID NOT FALL INTO THE PATIENT¿S BODY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147436 ↗
• MalfunctionSep 28, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB/GYN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10593212 ↗
• InjuryAug 19, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ATHEROMA SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. THE ATHEROMA WAS ON THE BACK. THE SUTURE SIZE WAS 1.5 CM. DURING THE SURGERY, AFTER PUTTING 2 TO 3 STITCHES, THE NEEDLE COULD NOT BE PASSED THROUGH THE TISSUE SMOOTHLY. THE NEEDLE WAS MOVED FROM THE SUBCUTANEOUS TO DERMA. THE DERMA OF THE BACK WAS STIFF. THE SURGEON FELT THAT THE NEEDLE WAS CHANGING SHAPES. THE NEEDLE WAS PULLED OUT FROM THE SUBCUTANEOUS INTO THE DERMIS, BUT THE AMOUNT OF TISSUE TAKEN AGAINST THE NEEDLE WAS TOO LARGE. THE NEEDLE DID NOT COME OUT SUFFICIENTLY IN THE CROSS SECTION OF THE WOUND AND THE TIP WAS GRASPED TO PULL IT OUT, SO IT WAS REPORTED POSSIBLE THAT THE NEEDLE TIP WAS DAMAGED THERE. IT WAS REPORTED THAT PERHAPS THE SURGEON DID NOT HAVE ENOUGH MOVEMENT ALONG THE CURVE WHEN THEY MOVED THE NEEDLE. THEN, WHEN THE SURGEON CHECKED THE NEEDLE TIP, IT SEEMED THAT THE NEEDLE TIP WAS NOT SHARP. THEY COMPARED THE NEEDLE WITH ANOTHER NEW NEEDLE, AND THERE WAS A CLEAR DIFFERENCE WITH THE SHARPNESS OF THE NEEDLE TIPS. SINCE THE NEEDLE TIP WAS MISSING, CT WAS TAKEN. THEN, A SHADOW ABOUT 1MM LENGTH WAS OBSERVED. BUT IT COULD NOT BE DETERMINED AS THE BROKEN NEEDLE TIP. IT W

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10426717 ↗
• MalfunctionApr 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOSCOPIC OB-GYN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, WHEN A SCRUB NURSE WAS OPENING THE PACKAGE ON THE MAYO TABLE FOR USING DERMAL SUTURING OF TROCAR HOLE, IT WAS FOUND THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE BEGINNING. IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS OBSERVED THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE FROM THE BEGINNING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9995214 ↗
• MalfunctionMar 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BENT. THE SURGEON STOPPED USING THE NEEDLE-SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, THE TIP OF THE NEEDLE WAS BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780460 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. THE SURGEON FELT SOMETHING UNUSUAL ON THE NEEDLE TIP DURING THE FIRST PASSING OF THE NEEDLE THROUGH THE TISSUE. ANOTHER NEEDLE-SUTURE WAS USED FOR THE PATIENT. NO DEVICES WERE LEFT IN THE PATIENT. THE LOT NUMBER IS UNKNOWN. FURTHER DETAILS ARE NOT PROVIDED THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION OF THE SAMPLE, IT WAS NOTED THE NEEDLE TIP WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253516 ↗