Caprosyn SC-5689GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521034891), received between Sep 13, 2017 and Sep 15, 2023 — classified as 1 injury, 4 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.

• MalfunctionSep 15, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, AT THE TIME OF WOUND CLOSURE, THE THREAD BROKE. TO RESOLVE THE ISSUE, THE NURSE OPENED A DIFFERENT LOT NUMBER OR BOX, AND THERE WAS NO ISSUE WITH THE NEW SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761420 ↗
• InjuryJun 20, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE NEEDLE BROKE AND FELL INTO PATIENT CAVITY. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE PIECE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17164703 ↗
• MalfunctionMar 1, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC SURGERY, WHILE ON USE, THE NEEDLE BROKE. ANOTHER SAME SUTURE WAS PULLED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16463556 ↗
• MalfunctionFeb 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY SURGERY. THE SUTURE DETACHED FROM NEEDLE WHILE SUTURING THE GINGIVA POST-TOOTH EXTRACTION. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728051 ↗
• MalfunctionSep 13, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN EAR SUTURING PROCEDURE. THE SUTURE WAS BEING APPLIED TO THE SKIN. THE SUTURE THREAD BROKE DURING KNOT TYING. THE SURGEON WAS EMPLOYING THE INTERRUPTED SUTURING TECHNIQUE. THE ABSORBABLE SUTURE HAD BEEN OPENED FOR THIRTY MINUTES PRIOR TO USE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED A NEW SUTURE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861118 ↗