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Cook G10360Recalls & reported problems

Cook Incorporated · Percutaneous Entry Needle · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002103603), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (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

  • Difficult to Advance1
  • Difficult to Remove1
  • Material Protrusion/Extrusion1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1
  • Pain1

Recent adverse event reports

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

  • InjuryOct 12, 2020Difficult to Remove; Difficult to Advance; Material Protrusion/Extrusion; Difficult to Remove; Difficult to Advance; Material Protrusion/Extrusion

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

    MAUDE report 10665210 ↗

Other Trocar devices

All Trocar devices →

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