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Cook G03100Recalls & reported problems

Cook Incorporated · Endoscopic Cholangiography Set · Class 1

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 00827002031005), received between Mar 23, 2017 and Mar 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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

  • Leak/Splash1

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.

  • MalfunctionMar 23, 2017Leak/Splash; Leak/Splash

    INTERNATIONAL CUSTOMER REPORTED THAT TWELVE (12) ENDOSCOPIC CHOLANGIOGRAPHY SET PROXIMAL CONNECTORS WERE LOOSE AND PRONE TO LEAKING. THE CONDITION PERSISTS EVEN AFTER REPORTEDLY TIGHTENING THE CONNECTIONS. IT IS NOT KNOWN WHEN THE DEVICE CONDITION WAS IDENTIFIED NOR THE ACTIONS TAKEN TO ADDRESS THE ISSUE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6427219 ↗

Other CATHETER, CHOLANGIOGRAPHY devices

All CATHETER, CHOLANGIOGRAPHY devices →

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