PDS D8588Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031030626), received between Feb 27, 2020 and Feb 28, 2020 — classified as 9 malfunctions.

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

• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE WHILE SUTURING, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE NEEDLE TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING UNKNOWN SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767952 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE WHILE SUTURING, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE NEEDLE TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING UNKNOWN SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767913 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE RUPTURE/BREAKAGE OCCURRED THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767866 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE RUPTURE/BREAKAGE OCCURRED THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767855 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE RUPTURE/BREAKAGE OCCURRED THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767845 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE WHILE SUTURING, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE NEEDLE TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING UNKNOWN SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767793 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE WHILE SUTURING, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE NEEDLE TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING UNKNOWN SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767790 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE WHILE SUTURING, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE NEEDLE TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING UNKNOWN SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767785 ↗
• MalfunctionFeb 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKE WHILE SUTURING, UNKNOWN LAYER OF TISSUE, UNKNOWN LOOP. THE NEEDLE TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING UNKNOWN SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765333 ↗