MAUDE Adverse Event Report: OLSEN MEDICAL LLC OLSEN MIDAS TOUCH; MONOPOLAR PENCIL

Model Number	75800
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have reached out to the end user for additional information with no response yet.The dhr for this lot number was reviewed with no issues found related to the reported complaint.All devices were visually inspected 100% by manufacturing during packaging.There has been a total of (b)(4) sold of all lots with one additional complaint recorded for a similar occurrence in 2017 ((b)(4) complaint rate) once we have additional information and have completed our investigation a follow up report will be submitted.The report is being submitted late as we recently discovered that our passed attempts to submit were not received due to an old version of esubmitter.
Event or Problem Description
The customer alleged that the blue button detached from the hand piece while in use in the operative field.It was retrieved and removed from the table.There was no harm to the patient.
Additional Manufacturer Narrative
After multiple attempts, no additional information was provided and the device was not returned for investigation.As a result, no further actions can be taken and the complaint will be closed.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions a follow up report will be submitted.This report is being submitted late as recently discovered that our reports were not being accepted due to an old version of esubmitter.

• Brand Name: OLSEN MIDAS TOUCH
• Common Device Name: MONOPOLAR PENCIL
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• Manufacturer (Section G): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13508569
• Report Number: 3000719969-2021-00002
• Device Sequence Number: 6432048
• Product Code: GEI
• UDI-Device Identifier: 00841785109041
• UDI-Public: 00841785109041
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K885200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 75800
• Device Catalogue Number: 75800
• Device Lot Number: 120200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown