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

Model Number	50-2111
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receiving the returned instrument, it was confirmed that the cord had burnt into two pieces near the instrument connection side of the instrument.Based on the lot number on the cord, it can be determined that the cord was purchased in (b)(6) 2017.The ifu states that each olsen reusable device is designed to withstand 20 sterilization cycles when properly cared for and sterilized per the instructions for use.The returned cored had been in use for approximately 2.5 years and had significant signs of wear and tear.The fire that occurred is the result of extensive bending where the cord connects to the bipolar forceps.With significant bending in the same spot the internal wires of the cord with begin to wear.There has been a total of 3,711 sold since 2013 with 4 complaints recorded for similar occurrences (0.1%) in all other cases, the cord has been used for a significant amount of time.Based on this information, this can be seen as the final report.If additional information is obtained that alleges any othe patient involvement or need for corrective actions, a follow up report will be submitted.
Event or Problem Description
The monopolar cord quit working during the case.The tech in the room adjusted the cord connection and it started working again but a small flame rose from the cord near the monopolar scissor connection.It went out immediately with no harm to the patient or user.The equipment was removed from the filed and new equipment was used to complete the case with no other issues.

• Brand Name: OLSEN
• Common Device Name: MONOPOLAR CORD
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• MDR Report Key: 9648540
• Report Number: 3000719969-2020-00001
• Device Sequence Number: 11376695
• Product Code: GEI
• UDI-Device Identifier: 00841785107665
• UDI-Public: 00841785107665
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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: Health Professional
• Device Model Number: 50-2111
• Device Catalogue Number: 50-2111
• Device Lot Number: 103799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1