ManoScan MSS-3598Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290101365600), received between Jun 17, 2019 and Jun 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2019Material Separation

  DURING ANORECTAL MANOMETRY PROCEDURE PATIENT WAS NOT COOPERATING. WHEN PHYSICIAN REMOVED MANOMETER FROM PATIENT, CATHETER CAME OUT BUT BALLOON AND DENTAL FLOSS WERE RETAINED IN PATIENT RECTUM. UNABLE TO BE MANUALLY REMOVED. PATIENT DID NOT PASS BALLOON WHILE AT HOSPITAL OR FOLLOW DIRECTIONS TO MONITOR STOOL FOR PASSAGE OF BALLOON POST-OP. THE BALLOON IS ABOUT 2 INCHES LONG AND TIED TO MANOMETER WITH 2 PIECES OF DENTAL FLOSS.

  Patient problems: Foreign Body In Patient

  MAUDE report 8703389 ↗