MAUDE Adverse Event Report: OLSEN MEDICAL LLC CONMED; MONOPOLAR CORD

Model Number	60-5169-001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was not able to provide pictures, the lot number, or return the device for evaluation.Without this information the device history record cannot be reviewed and a true root cause cannot be determined.There has been a total of 2,828 sold of this cord since 2016 with 4 additional complaints recorded for similar occurrences.In each occurrence, the device was either not returned for evaluation or the root cause was determined to be wear and tear of the cord.The ifu for this products recommends a twenty uses.Due to the lack of information, this can be seen as the final report.If additional information is obtained that alleges additional patient involvement or the need for corrective actions, a follow up report will be submitted.
Event or Problem Description
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.

• Brand Name: CONMED
• Common Device Name: MONOPOLAR CORD
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center place; louisville KY 40211
• MDR Report Key: 10906951
• Report Number: 3000719969-2020-00007
• Device Sequence Number: 4258685
• Product Code: GEI
• UDI-Device Identifier: 00841785113369
• UDI-Public: 00841785113369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 60-5169-001
• Device Catalogue Number: 60-5169-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1