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ACS JRSU11GRecalls & reported problems

American Contract Systems, Inc. · UNIVERSAL SET-UP PACK 147298 · Class 2

Data updated Oct 18, 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 00191072140548), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 2026.

Most reported problems

Device problems

  • Use of Device Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

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

  • InjuryJun 20, 2023Use of Device Problem; Use of Device Problem

    A BOVIE PENCIL FROM UNIVERSAL SET-UP PACK ACTIVATED ON ITS OWN WHEN THE PLUG WAS INSERTED INTO THE ROBOT. THE PATIENT WAS ALREADY PREPPED AND DRAPED FOR THE PROCEDURE, NO ONE WAS UTILIZING THE BOVIE PENCIL AT THAT TIME. THE STAFF HEARD A BUZZING SOUND AND IMMEDIATELY REALIZED IT WAS THE BOVIE PENCIL. THE NURSE PULLED THE PLUG, AND THE SCRUB TECH THREW DEVICE OFF THE STERILE FIELD. UNFORTUNATELY, THE PATIENT WAS ALREADY BURNED.

    Patient problems: Burn(s)

    MAUDE report 17167954 ↗

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Sources and updates

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