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Williams G14220Recalls & 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 00827002142206), received between Nov 29, 2018 and Nov 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

  • Device Contamination with Chemical or Other Material1
  • Structural Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionNov 29, 2018Structural Problem; Device Contamination with Chemical or Other Material

    IT WAS REPORTED AN ISSUE WITH CYSTOSCOPIC INJECTION NEEDLE WHICH MADE THE DEVICE UNUSABLE. IT WAS FURTHER NOTED A LONGITUDINAL SPLIT ON A DILATOR COVERED WITH AN UNKNOWN SUBSTANCE. IN ADDITION, THE HUB WAS BENT. THERE WAS NO CLINICAL CONSEQUENCES REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8116329 ↗

Other endoscopic injection needle, gastroenterology-urology devices

All endoscopic injection needle, gastroenterology-urology devices →

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