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A&E Medical / Disposable Suction Coagulator 050-005Recalls & reported problems

A & E Medical Corporation · Suction Coagulator, 1 per pouch · 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 10841291104865), received between Aug 10, 2017 and Aug 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Issue” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K881413); they may or may not involve this specific model.

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

  • Device Issue1
  • Device Operational Issue1

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.

  • InjuryAug 10, 2017Device Issue; Device Operational Issue; Device Issue; Device Operational Issue

    PATIENT WAS FOUND TO HAVE LOWER LIP SWELLING, THOUGHT TO BE DUE TO ELECTRICAL BURN FROM SUCTION COAGULATOR. PATIENT WAS TREATED WITH POLYSPORIN AND OBSERVED CLOSELY.

    Patient problems: Burn(s)

    MAUDE report 6786367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K881413. One submission often covers many models, so check the product and lot details in each record.

  • Z-0770-2014 · Dec 19, 2013 · Terminated
    Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by
  • Z-0771-2014 · Dec 19, 2013 · Terminated
    Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by

Other Electrosurgical, Cutting & Coagulation & Accessories devices

All Electrosurgical, Cutting & Coagulation & Accessories devices →

Sources and updates

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