S-ROM 87-5929Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295218814), received between Feb 19, 2020 and Apr 8, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9940085 ↗
• MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919396 ↗
• MalfunctionFeb 19, 2020Material Twisted/Bent; Material Twisted/Bent

  CALL FROM THE HOSPITAL TO REPLACE 3 INSTRUMENTS DUE TO WEAR AND TEAR. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728683 ↗