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Symmetry Olsen 20-1060KIRecalls & 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 00841785102813), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (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

  • Output Problem1

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.

  • MalfunctionFeb 15, 2022Output Problem

    THE CUSTOMER ALLEGED THAT AT THE BEGINNING OF THE PROCEDURE, IT WAS DISCOVERED THAT THE TIPS OF THE DISPOSABLE BIPOLARS CROSSED. PER THE DOCTOR, THIS IS BECOMING MORE COMMON. WHEN USING THE BIPOLAR FORCEPS AND THE TIPS CROSS, THERE IS AN INCREASED RISK FOR DAMAGE TO THE SURROUNDING TISSUES AND OTHER SURGICAL COMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13538627 ↗

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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