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ConMed 60-5169-001Recalls & reported problems

Aspen Surgical Products, Inc. · Class 2

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841785113369), received between Mar 17, 2020 and May 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fire” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K111262); 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: 0 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

  • Fire3
  • Sparking2
  • Device Fell1
  • Material Frayed1
  • Material Separation1
  • Smoking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 21, 2025Sparking; Sparking

    COMPLAINANT ALLEGES "60-5169-001: DURING A LAPAROSCOPIC CASE, THE CONMED MONOPOLAR CORD, WHICH WAS CONNECTED TO A LAPAROSCOPIC HOOK AND A VALLEYLAB FORCE FX, STARTED SPARKING, BROKE APART, AND CAUGHT THE SURGICAL DRAPE ON FIRE, RESULTING IN A HOLE THE SIZE OF THE QUARTER IN THE DRAPE. NO PATIENT INJURY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22060433 ↗
  • MalfunctionNov 25, 2020Fire; Material Frayed; Material Separation; Device Fell

    THE CUSTOMER ALLEGED THAT A FIRE STARTED WHILE THE SURGEON WAS USING AN L-HOOK ATTACHED TO THE MONOPOLAR CORD USING A COVIDIEN VALLEYLAB FT10 DURING THE SURGERY. THE CORD FRAYED NEAR THE PLASTIC END, CAME OFF, FELL INTO THE POCKET OF THE DRAPE AND STARTED THE FIRE. THE FIRE WAS EXTINGUISHED WITHIN SECONDS. THERE WAS NO HARM TO THE PATIENT OR THE STAFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10906951 ↗
  • MalfunctionNov 25, 2020Fire

    THE CUSTOMER ALLEGED THAT DURING A PROCEDURE THE LAPAROSCOPIC MONOPOLAR CORD CAUGHT FIRE. ANOTHER LAPAROSCOPIC MONOPOLAR CORD WAS USED TO COMPLETE THE SURGERY. THE FIRE WAS EXTINGUISHED AND THERE WAS NO PATIENT OR USER HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10906828 ↗
  • MalfunctionMar 17, 2020Fire; Smoking; Sparking

    DURING A SCHEDULED PROCEDURE, THE PHYSICIAN ATTACHED THE CORD TO A LAPAROSCOPIC INSTRUMENT, PREPARING FOR USE. THE SURGICAL TEAM SAW SMOKE, SPARKS, AND A SMALL FLAME BETWEEN THE CORD AND THE CORD ATTACHMENT ON THE INSTRUMENT. THEY IMMEDIATELY REMOVED THE CORD FROM THE ATTACHMENT, SURGICAL FIELD AND POWER. THE INCIDENT DID NOT AFFECT THE PATIENT, SURGICAL DRAPES, OR THE SURGICAL TEAM. THE CORD WAS REPLACED WITH A NEW CORD AND THE TEAM PRECEDED WITH THE PROCEDURE WITH NO FURTHER IMPLICATIONS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9843011 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111262. One submission often covers many models, so check the product and lot details in each record.

  • Z-1943-2018 · May 11, 2018 · Terminated
    Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40
  • Z-1942-2018 · May 11, 2018 · Terminated
    Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m),

Other Electrosurgical, Cutting & Coagulation & Accessories devices

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Sources and updates

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