MAUDE Adverse Event Report: OLSEN MEDICAL LLC SYMMETRY OLSEN; BIPOLAR FORCEPS

Catalog Number	20-1060K
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.However, it was returned to the manufacturing location for testing and proper evaluation.There have been a total of (b)(4) units sold since 2013 with one additional complaint recorded for a similar occurrence.A follow up a report will be submitted once the evaluation has been completed.
Event or Problem Description
The customer alleged that during the start of the procedure, the foot pedal was pressed and the tips created a spark when they were initial touched together.The spark was replicated outside the body when the doctor placed the tips together and stepped on the pedal.
Additional Manufacturer Narrative
Upon receiving the device, it was noted that there was burnt material on the tips of the device.Based on the information provided by the customer, the tips sparked when they were brought together to grab the tissue and the issue occurred again outside the patient when the surgeon touched the tips together.This spark that occurred was most likely the result of arching of the device that was caused by touching the tips together or coming into contact with metal instrument while using inside the patient.The returned device was found to be functioning properly.A dhr review was completed for product 20-1060k with lot number 124509.There were no noted nonconformities during manufacturing and processing of this product and lot number.All items were noted as within manufacturing specification from the manufacturer.Based on the evaluation of the device, no further actions are required.If additional information is obtained that alleges any additional patient involvement or additional pertinent information for the investigation, a follow up report will be submitted.

• Brand Name: SYMMETRY OLSEN
• Common Device Name: BIPOLAR FORCEPS
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville KY 40211
• Manufacturer (Section G): OLSEN MEDICAL LLC; 3230 commerce center plaza; louisville KY 40211
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 15228425
• Report Number: 3000719969-2022-00001
• Device Sequence Number: 11905184
• Product Code: GEI
• UDI-Device Identifier: 30841785102791
• UDI-Public: 30841785102791
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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 Catalogue Number: 20-1060K
• Device Lot Number: 124509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown