n.a. 27033W-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551393062), received between Apr 14, 2017 and Apr 14, 2017 — classified as 1 injury.

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

• InjuryApr 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, THE PATIENT WAS SCHEDULED FOR A CYSTOSCOPY WITH TRANSURETHRAL INCISION OF POSTERIOR URETHRAL VALVES AND CIRCUMCISION. DURING CYSTOSCOPY, PATENT BECAME HEMODYNAMICALLY UNSTABLE AND PROCEDURE WAS STOPPED. THE PATIENT WAS STABILIZED AND TRANSFERRED TO PEDIATRIC INTENSIVE CARE UNIT (PICU) WHERE HE CONTINUED TO DECOMPENSATE. AFTER APPROXIMATELY 3 HOURS, HE RETURNED TO THE OPERATING ROOM FOR A STAT EXPLORATORY LAPAROTOMY AND IT WAS DISCOVERED THAT THE LEFT ILIAC VEIN AND ARTERY WAS LACERATED. THE VESSELS WERE IMMEDIATELY CLAMPED TO CONTROL BLEEDING. THE VASCULAR TEAM WAS CONTACTED AND THE ARTERY WAS REPAIRED WITHOUT DIFFICULTY. THE PATIENT IMPROVED IMMEDIATELY AND WAS READMITTED TO THE PICU FOR FOUR DAYS. HE WAS LATER TRANSFERRED TO AN INPATIENT ROOM AND DISCHARGED ELEVEN DAYS AFTER ADMISSION.

  Patient problems: Laceration(s)

  MAUDE report 6494698 ↗