S-ROM 53-4500RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295171980), received between Dec 16, 2019 and Jul 14, 2022 — classified as 3 malfunctions.

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

Recent adverse event reports

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

• MalfunctionJul 14, 2022Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE HOSPITAL RECEIVED DIRTY INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014371 ↗
• MalfunctionJun 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SLEEVE EXTRACTOR BENT DURING EXTRACTION. NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572275 ↗
• MalfunctionDec 16, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT NOTHING WAS DELAYED. THE SLEEVE EXTRACTOR WAS NOT ABLE TO BE REMOVED AND THE LOOP BROKE AT THE LOOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475834 ↗