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Acucise® Endopyelotomy System B1005Recalls & reported problems

Applied Medical Resources Corporation · Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT. BOX/10, CE UROWIRE · Class 2

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 00607915111663), received between Apr 17, 2017 and Apr 17, 2017 — 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 Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionApr 17, 2017Break; Break

    CYSTO RPG URETEROSCOPY AND POSSIBLE ENDOPYELOTOMY - THE BALLOON BURST DURING SURGERY. IT WAS NOT KNOWN HOW MANY TIMES AND HOW LONG THE CUTTING WIRE WAS ACTIVATED. THE COORDINATOR NOTED THE PRODUCT WAS RELATED TO A BK024 ACUCISE PACK. TYPE OF INTERVENTION: OPENED A 2ND KIT. PATIENT STATUS: NO PATIENT INJURY REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6499095 ↗

Other Accessories, Catheter, G-U devices

All Accessories, Catheter, G-U devices →

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