PDS PDP317HRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10705031048034), received between Jun 25, 2018 and Oct 2, 2025 — classified as 5 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT SNAPPING SUTURE CAUSED PET TO HERNIATE THE ABDOMEN. SUTURE WAS BREAKING CAUSING THE PET TO HAVE SECONDARY SURGERY. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 23199387 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERITONEAL CLOSURE IN CESAPE (VIA LSK) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IMMEDIATELY BROKE UNDER TENSION (AT THE KNOT OR WITH CONTINUOUS SUTURES). DURING USE ON PATIENT. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. IT COST 15 EXTRA MINUTES OF SURGERY DURATION. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960509 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERITONEAL CLOSURE IN CESAPE (VIA LSK) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IMMEDIATELY BROKE UNDER TENSION (AT THE KNOT OR WITH CONTINUOUS SUTURES). DURING USE ON PATIENT. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. IT COST 15 EXTRA MINUTES OF SURGERY DURATION. PROCEDURE FINISHED WITH SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960499 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AT THE TIME OF REINFORCING THE STAPLING LINE, THE SUTURE WAS PULLED AND THE NEEDLE FLEW OUT, THUS DISASSEMBLING THE THREAD NEEDLE. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862399 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861987 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE IS CUT DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633865 ↗
• MalfunctionJan 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING SUTURE REINFORCEMENT, THE THREAD IS RELEASED FROM THE NEEDLE, A NEW SUTURE IS PASSED OUT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258228 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS CUT REPEATEDLY WHEN USED DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522570 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS CUT REPEATEDLY WHEN USED DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522558 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS CUT REPEATEDLY WHEN USED DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522410 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD IS CUT REPEATEDLY WHEN USED DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522403 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE THREAD IS CUT REPEATEDLY WHEN USED DURING SURGERY, SURGEONS. THERE WERE NOT PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514031 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE THREAD IS CUT REPEATEDLY WHEN USED DURING SURGERY, SURGEONS. THERE WERE NOT PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513846 ↗
• MalfunctionAug 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS INTRODUCED THROUGH THE TROCAR. WHEN THE NEEDLE IS BEING RETRIEVED TO PASS THE FIRST STITCH, THE NEEDLE REMAINS MOUNTED ON THE NEEDLE HOLDER AND THE THREAD COMES APART. A NEW SUTURE IS PASSED TO CONTINUE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001958 ↗
• MalfunctionMar 28, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SMALL BOWEL RESECTION ON (B)(6) 2024 AND SUTURE WAS USED. THE THREAD CAME LOOSE FROM THE NEEDLE AND THE THREAD BROKE DURING SUTURING. A NEW SUTURE WAS TAKEN AND PLACED. THE PROCEDURE WAS PROLONGED BY 8 MINUTES AS A RESULT OF THE EVENT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993828 ↗
• MalfunctionMar 28, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SMALL BOWEL RESECTION ON (B)(6) 2024 AND SUTURE WAS USED. THE THREAD CAME LOOSE FROM THE NEEDLE AND THE THREAD BROKE DURING SUTURING. A NEW SUTURE WAS TAKEN AND PLACED. THE PROCEDURE WAS PROLONGED BY 8 MINUTES AS A RESULT OF THE EVENT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991170 ↗
• MalfunctionOct 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY SEVERAL NEEDLES CAME APART FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927406 ↗
• MalfunctionOct 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE THEY WERE GOING THROUGH TOUGH SKIN AND A COUPLE OF THE NEEDLES BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927360 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL FLAP DERMAL PLANE. IN ABOUT 3 WEEKS TO 2 MONTHS, THE PATIENT DEVELOPED A SMALL INCREASE IN VOLUME IN THE SCAR AREA, PAIN AND SUBSEQUENT LEAKAGE OF VISCOUS FLUID AND WOUND DESHICENCE IN THE LATERAL AREA WITHOUT TENSION. THE SUTURE WAS EXPOSED AND THE INFLAMMATION SUBSIDED AS THE SUTURE MATERIAL WAS REMOVED. THESE PHENOMENA WERE REPEATED MANY TIMES IN THE SAME PATIENT IN DIFFERENT AREAS OF THE OPERATIVE WOUND, HAVING TO REMOVE THE SUTURE MATERIAL REPEATEDLY. THE PATIENT WAS MANAGED WITH ADVANCED HEALING UNTIL CLOSURE.

  Patient problems: Fluid Discharge; Impaired Healing; Inflammation; Wound Dehiscence

  MAUDE report 17860647 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL FLAP DERMAL PLANE. IN ABOUT 3 WEEKS TO 2 MONTHS, THE PATIENT DEVELOPED A SMALL INCREASE IN VOLUME IN THE SCAR AREA, PAIN AND SUBSEQUENT LEAKAGE OF VISCOUS FLUID AND WOUND DEHISCENCE IN THE LATERAL AREA WITHOUT TENSION. THE SUTURE WAS EXPOSED AND THE INFLAMMATION SUBSIDED AS THE SUTURE MATERIAL WAS REMOVED. THESE PHENOMENA WERE REPEATED MANY TIMES IN THE SAME PATIENT IN DIFFERENT AREAS OF THE OPERATIVE WOUND, HAVING TO REMOVE THE SUTURE MATERIAL REPEATEDLY. THE PATIENT WAS MANAGED WITH ADVANCED HEALING UNTIL CLOSURE.

  Patient problems: Fluid Discharge; Impaired Healing; Inflammation; Wound Dehiscence

  MAUDE report 17860641 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL FLAP DERMAL PLANE. IN ABOUT 3 WEEKS TO 2 MONTHS, THE PATIENT DEVELOPED A SMALL INCREASE IN VOLUME IN THE SCAR AREA, PAIN AND SUBSEQUENT LEAKAGE OF VISCOUS FLUID AND WOUND DEHISCENCE IN THE LATERAL AREA WITHOUT TENSION. THE SUTURE WAS EXPOSED AND THE INFLAMMATION SUBSIDED AS THE SUTURE MATERIAL WAS REMOVED. THESE PHENOMENA WERE REPEATED MANY TIMES IN THE SAME PATIENT IN DIFFERENT AREAS OF THE OPERATIVE WOUND, HAVING TO REMOVE THE SUTURE MATERIAL REPEATEDLY. THE PATIENT WAS MANAGED WITH ADVANCED HEALING UNTIL CLOSURE.

  Patient problems: Fluid Discharge; Impaired Healing; Inflammation; Wound Dehiscence

  MAUDE report 17860639 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE ABDOMINAL FLAP DERMAL PLANE. IN ABOUT 3 WEEKS TO 2 MONTHS, THE PATIENT DEVELOPED A SMALL INCREASE IN VOLUME IN THE SCAR AREA, PAIN AND SUBSEQUENT LEAKAGE OF VISCOUS FLUID AND WOUND DEHISCENCE IN THE LATERAL AREA WITHOUT TENSION. THE SUTURE WAS EXPOSED AND THE INFLAMMATION SUBSIDED AS THE SUTURE MATERIAL WAS REMOVED. THESE PHENOMENA WERE REPEATED MANY TIMES IN THE SAME PATIENT IN DIFFERENT AREAS OF THE OPERATIVE WOUND, HAVING TO REMOVE THE SUTURE MATERIAL REPEATEDLY. THE PATIENT WAS MANAGED WITH ADVANCED HEALING UNTIL CLOSURE.

  Patient problems: Fluid Discharge; Impaired Healing; Inflammation; Wound Dehiscence

  MAUDE report 17860638 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TWO MONTHS AFTER ABDOMINOPLASTY, FIRST, THE AREA IS INFLAMED AND CLOUDY SEROUS FLUID BEGINS TO EMERGE. THEN, THE SUTURE MATERIAL IS EXPOSED AND THE WOUND IS OPENED WITH DEHISCENCE. PROLONGED CURES, ANTIBIOTIC THERAPY, SUMMARIZATION, VACUUM HEALING ARE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Impaired Healing; Inflammation; Wound Dehiscence

  MAUDE report 17860634 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. SUTURE ARE BECOMING DETACHED FROM THE NEEDLE AFTER 3-4 THROWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481810 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. SUTURE ARE BECOMING DETACHED FROM THE NEEDLE AFTER 3-4 THROWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481765 ↗