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Symmetry Olsen 20-1082KIRecalls & reported problems

Aspen Surgical Products, Inc. · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841785103001), received between May 20, 2025 and Jun 12, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Excessive Heating1
  • Insufficient Device Problem Information1

Patient problems

  • Superficial (First Degree) Burn2
  • Upper Respiratory Tract Injury1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    COMPLAINANT ALLEGES "A PATIENT WAS BURNED WITH OUR BIPOLAR."

    Patient problems: Superficial (First Degree) Burn

    MAUDE report 22196542 ↗
  • InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Excessive Heating; Adverse Event Without Identified Device or Use Problem; Excessive Heating

    COMPLAINANT ALLEGES THAT A PATIENT WAS BURNED WITH OUR BIPOLAR UNIT DURING AN OPEN NECK PROCEDURE. THE PATIENT'S TRACHEA WAS BURNED.

    Patient problems: Superficial (First Degree) Burn; Upper Respiratory Tract Injury

    MAUDE report 22056377 ↗

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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