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
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 · TerminatedSymmetry 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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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