MAUDE Adverse Event Report: OLSEN MEDICAL LLC MIDAS TOUCH; OLSEN BLADE ELECTRODE, MIDAS TOUCH

Model Number	30-0014
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was utilizing an electro cautery blade, when using the device for approximately 10 minutes the sheath around the end fell apart.No fragments in the patient.

• Brand Name: MIDAS TOUCH
• Common Device Name: OLSEN BLADE ELECTRODE, MIDAS TOUCH
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center place; louisville KY 40211
• MDR Report Key: 7394012
• Report Number: 3000719969-2018-00004
• Device Sequence Number: 1314695
• Product Code: GEI
• UDI-Device Identifier: 30841785106232
• UDI-Public: 30841785106232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K973234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

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 Expiration Date: 02/28/2018
• Device Model Number: 30-0014
• Device Catalogue Number: 30-0014
• Device Lot Number: 027133
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2018
• Patient Sequence Number: 1
• Patient Age: 36 YR