PDS Z468HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031061095), received between Nov 6, 2019 and Mar 8, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE AND SUTURE DISCONNECTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869214 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS STATED THAT THE BROKEN RATE IS ABOUT 20%. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595588 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT WAS STATED THAT THE BROKEN RATE IS ABOUT 20%. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587126 ↗
• InjuryNov 6, 2019Break; Break

  GYNAE PATIENT¿S WOUNDS OPENED POST-OP AFTER 3 DAYS. WOUNDS HAD TO BE CLOSED IN THEATRE AGAIN. IT IS UNKNOWN IF THE PATIENT HAD ANY INFECTIONS OR OTHER CO-MORBIDITIES. I HAVE ASKED THE PHARMACIST TO PLEASE INVESTIGATE THE CO-MORBIDITIES OF THE PATIENT.

  Patient problems: Not Applicable

  MAUDE report 9288826 ↗
• InjuryNov 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT¿S WOUNDS OPENED POST-OP WITHIN 24 HOURS. THE SUTURE BROKE IN THE MIDDLE OF THE SUTURE LINE, IT WAS A CONTINUOUS SUTURING TECHNIQUE. THE SURGEON HAD TO TAKE THE PATIENT BACK TO THEATRE TO CLOSE THE WOUND VIA LAPAROTOMY. IT IS UNKNOWN IF THE PATIENT HAD ANY INFECTIONS OR OTHER CO-MORBIDITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 9286495 ↗