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Symmetry Olsen 20-1060KRecalls & reported problems

Aspen Surgical Products, Inc. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00841785102790), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K130669); 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

  • Sparking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 15, 2022Sparking

    THE CUSTOMER ALLEGED THAT DURING THE START OF THE PROCEDURE, THE FOOT PEDAL WAS PRESSED AND THE TIPS CREATED A SPARK WHEN THEY WERE INITIAL TOUCHED TOGETHER. THE SPARK WAS REPLICATED OUTSIDE THE BODY WHEN THE DOCTOR PLACED THE TIPS TOGETHER AND STEPPED ON THE PEDAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15228425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130669. One submission often covers many models, so check the product and lot details in each record.

  • Z-1944-2018 · May 11, 2018 · Terminated
    Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15

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Sources and updates

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