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NA 223173Recalls & reported problems

Medos International Sàrl · FREE NEEDLE LOOP REVERSE CUTTING NEEDLE WITH STAINLESS STEEL WIRE LOOP 36mm 1/2 c REVERSE CUTTING N=1 OS-6 · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20886705030559), received between May 4, 2022 and May 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 4, 2022Break; Break

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE OF THE DYNATAPETM SUTURE, WHITE/BLACK BRAIDED FLAT SUTURE, 6/PACK WAS FRAYED AND THE NEEDLE WITH STAINLESS STEEL WIRE LOOP, 12 PK BROKE. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14281090 ↗

Other NEEDLE, SUTURING, DISPOSABLE devices

All NEEDLE, SUTURING, DISPOSABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.