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Williams G16684Recalls & reported problems

Cook Incorporated · Williams Cystoscopic Injection Needle · 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 00827002166844), received between Feb 26, 2015 and Feb 26, 2015 — 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

Device problems

  • Material Separation1

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.

  • MalfunctionFeb 26, 2015Material Separation

    DURING A TJF40 ACE-TREATMENT PROCEDURE ON A (B)(4) FEMALE PT. THE CYTOSCOPE WAS IN THE PT'S BLADDER AND THE COOK INJECTION NEEDLE WAS IN THE CYTOSCOPE WORKING CHANNEL, DEFLUX WAS INJECTED AND WHEN THE USER REMOVED THE INJECTION NEEDLE, IT WAS FOUND THAT THE NEEDLE WAS BROKEN. DURING RINSING OF THE CYTOSCOPE, THE BROKEN TIP PORTION OF THE NEEDLE WAS FOUND IN THE WORKING CHANNEL. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 4577517 ↗

Other endoscopic injection needle, gastroenterology-urology devices

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