PDS Z315HRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031060456), received between Apr 22, 2020 and Oct 29, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE LINE SNAPPED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23416429 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE LINE SNAPPED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23416428 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. POST-OP, THE SUTURE LINE SNAPPED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23416427 ↗
• MalfunctionMay 16, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE QR CODE OF THE SUTURE DOES NOT WORK. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039202 ↗
• MalfunctionMay 16, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE QR CODE OF THE SUTURE DOES NOT WORK. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039193 ↗
• MalfunctionMay 16, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE QR CODE OF THE SUTURE DOES NOT WORK. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039188 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATES THAT WHEN TENSIONING THE PDS SUTURE, THE THREAD BREAKS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036758 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON TRIED TO REINFORCE THE DAMAGED PART OF THE COLON WITH DA VINCI. THE SUTURE WAS BROKEN DURING USE AT THE TIME OF WOUND CLOSURE. THIS HAPPENED IN 3 SUTURES IN A ROW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476483 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON TRIED TO REINFORCE THE DAMAGED PART OF THE COLON WITH DA VINCI. THE SUTURE WAS BROKEN DURING USE AT THE TIME OF WOUND CLOSURE. THIS HAPPENED IN 3 SUTURES IN A ROW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476480 ↗
• MalfunctionJan 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON TRIED TO REINFORCE THE DAMAGED PART OF THE COLON WITH DA VINCI. THE SUTURE WAS BROKEN DURING USE AT THE TIME OF WOUND CLOSURE. THIS HAPPENED IN 3 SUTURES IN A ROW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476470 ↗
• MalfunctionDec 7, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2022 AND A SUTURE WAS USED. THE SUTURE BROKE DURING USE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934571 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OBGYN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN AND CUT FROM THE NEEDLE DURING CONTINUOUS SUTURING. THE TIP OF THE NEEDLE DID NOT COME OUT WHEN THE SURGEON WAS SUTURING FAT, SO THE SURGEON WAS PULLING IT IN THE OPPOSITE DIRECTION AND TRIED TO REINSERT THE NEEDLE. AS A RESULT, THE SUTURE AND THE NEEDLE WERE CUT OFF. IT TOOK ABOUT 10 TO 15 MINUTES TO SEARCH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835148 ↗
• MalfunctionAug 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. THE SUTURE BROKE QUITE EASILY AND WAS NOT NORMAL QUALITY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350738 ↗
• MalfunctionAug 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. THE SUTURE BROKE QUITE EASILY AND WAS NOT NORMAL QUALITY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350737 ↗
• MalfunctionAug 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. THE SUTURE BROKE QUITE EASILY AND WAS NOT NORMAL QUALITY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350707 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON THE PERITONEUM IN THE ABDOMINAL CAVITY. IT WAS DETACHED EASILY WHEN PULLING THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701035 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON THE PERITONEUM IN THE ABDOMINAL CAVITY. IT WAS DETACHED EASILY WHEN PULLING THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701033 ↗
• MalfunctionApr 20, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSABDOMINAL PREPERITONEAL SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON THE PERITONEUM IN THE ABDOMINAL CAVITY. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11696636 ↗
• MalfunctionApr 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRECTOMY PROCEDURE USING HINGED DOUBLE DOOR METHOD ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE AFTER HOLDING THE SUTURE. WHEN PUTTING THE NEEDLE-SUTURE THROUGH THE TROCAR. IT WAS NOT A CONTROL RELEASE NEEDLE. THE NEEDLE FELL IN THE BODY BUT WAS RETRIEVED USING FORCEPS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986882 ↗