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
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 · TerminatedSymmetry 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 · TerminatedSymmetry 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),
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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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