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ACS GIDC79CRecalls & reported problems

American Contract Systems, Inc. · LAPAROSCOPY GYN PACK · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00191072042361), received between Jul 8, 2019 and Jul 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Microbial Contamination of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Microbial Contamination of Device1

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.

  • InjuryJul 8, 2019Microbial Contamination of Device

    HAIR FOUND IN CUSTOM D & C VAG HYST PACK WHEN OPENED. WAS ON TOP OF PREP TRAY. FDA SAFETY REPORT ID# (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8772727 ↗

Other General surgery tray devices

All General surgery tray devices →

Sources and updates

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