PDS Z334HRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705031060562), received between Jan 30, 2018 and Jun 4, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A ROBOTIC CASE; THE DOCTOR HAD A MISHAP A WEEK AGO WITH USING AN 0, SUTURE, ON A CT-2 NEEDLE WHICH BROKE, AND THERE IS A 4 MILLIMETER FRAGMENT INSIDE THE PATIENT. SURGICAL DELAY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Foreign Body In Patient

  MAUDE report 25399904 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND OF THE SUTURE BROKE EASILY DURING USE, AFTER THE INCIDENT SURGEON WAS ABLE TO EASILY BREAK THE SUTURE BY HAND. NO PATIENT HARM. A NEW/DIFFERENT SUTURE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517261 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A VAGINAL HYSTERECTOMY PROCEDURE THAT THE TIP OF THE NEEDLE BROKE OFF. TIP COULD NOT BE FOUND DURING X-RAY. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031320 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES BROKE DURING THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837033 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, TWO SUTURES BROKE DURING THE CASE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837027 ↗
• MalfunctionAug 14, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED INCORRECT ARTICLE INFORMATION ON FOIL AND BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547395 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623939 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STITCH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623911 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623908 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623907 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623902 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623901 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623889 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623767 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623757 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RIPPED APART AT KNOTTING A SIMPLE INTERRUPTED STICH THROUGH FASCIA. IT WAS FINALLY SUTURED WITH A DIFFERENT SUTURE THAT HAD A STRENGTH OF 1. THERE WAS NO SIGNIFICANT DELAY REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623752 ↗
• MalfunctionSep 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE WHILE SEWING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502277 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C3-C4 LAMINECTOMY PROCEDURE AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF WHILE CLOSING THE INCISION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713144 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656759 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656611 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE WAS BREAKING UNDER NORMAL TENSION, WHILE TYING. A NEW SUTURE OPENED FROM BOX TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339938 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE WAS BREAKING UNDER NORMAL TENSION, WHILE TYING. A NEW SUTURE OPENED FROM BOX TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339933 ↗
• MalfunctionJul 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF WHILE TYING A KNOT AT THE END OF THE SUTURE LINE. NO ADDITIONAL SUTURES WERE NEEDED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144199 ↗
• MalfunctionMar 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531775 ↗
• MalfunctionMar 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531724 ↗