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

Model Number	90020
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received any details, including the part number involved as the customer has not responded.Part 90020 was chosen for the report as it is purchased the most often by our distributor in (b)(4).There has been a total of (b)(4) sold of this part number with on additional complaint recorded for the cord shorting out, and no longer working.A follow up report will be submitted once further details are received, or if we decide to close the complaint.
Event or Problem Description
The customer alleged that during the middle of the surgery, the cable burst.
Additional Manufacturer Narrative
Two lot numbers of 90020 were returned lot# 116966 and lot# 112530.It is unknown if both or one were involved in the reported event.Lot# 116966 was purchased in april 2020 and lot# 112530 was purchased in july 2019.The returned devices are still being evaluated by the manufacturing location.Additionally, we have requested some additional information from the customer to help with our investigation.A follow up report will be submitted once we have completed our investigation or significant additional information is received.

• Brand Name: OLSEN
• Common Device Name: MONOPOLAR CABLE
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• MDR Report Key: 10775061
• Report Number: 3000719969-2020-00005
• Device Sequence Number: 2960263
• Product Code: GEI
• UDI-Device Identifier: 00841785110061
• UDI-Public: 00841785110061
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 90020
• Device Catalogue Number: 90020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1