PDS Z880GRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031061903), received between Dec 26, 2018 and Mar 4, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN OPEN COLECTOMY PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED ON THE FASCIA. DURING THE PROCEDURE, WHILE SUTURING THE FACIA DURING CLOSURE, THE NEEDLE BROKE. PATIENTS FACIA WAS HEAVILY SCARRED AND MAY HAVE CONTRIBUTED TO THE NEEDLE BREAKING. FRAGMENT WAS RETRIEVED WITHOUT ANY ADDITIONAL MEASURES BEING TAKEN. ANOTHER LIKE DEVICE WAS USE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826698 ↗
• MalfunctionJul 13, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF SUTURE WHILE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009147 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL HYSTERECTOMY PROCEDURE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE WHILE TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973587 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL HYSTERECTOMY PROCEDURE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE WHILE TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973585 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL HYSTERECTOMY PROCEDURE AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE WHILE TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973580 ↗
• MalfunctionNov 15, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HAND-ASSISTED LAPAROSCOPIC NEPHRECTOMY PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING THE SURGERY, THE TIP OF THE NEEDLE BROKE. THE TIP WAS RETRIEVED AND REMOVED FROM THE STERILE FIELD. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9330203 ↗
• MalfunctionJan 8, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A HAND ASSISTED COLECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. DURING USE THE NEEDLE TIP BROKE OFF. THE SURGEON NOTED THAT HE GRABBED THE NEEDLE BY THE TIP AND THIS HAPPENED THE TIP POPPED OFF. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226519 ↗
• MalfunctionJan 8, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A HAND ASSISTED COLECTOMY ON (B)(6) 2018 AND SUTURE WAS USED. DURING USE THE NEEDLE TIP BROKE OFF. THE SURGEON NOTED THAT HE GRABBED THE NEEDLE BY THE TIP AND THIS HAPPENED THE TIP POPPED OFF. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226512 ↗
• MalfunctionDec 26, 2018Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE NEEDLE BROKE OFF INSIDE PATIENT. PIECE RETRIEVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196330 ↗