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

Model Number	20-1080K
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The customer stated that they were using power settings of 15 or 20.The device was tested on these setting and functioned as intended.The generator was turned up to 40w and the reported arcing that the customer reported could not duplicated.A true root cause cannot be accurately determined with the information provided, most likely the burn occurred due to user error as the forceps were functioning as intended.There has been a total of (b)(4) instruments sold with no additional complaint recorded for this issue.This is an isolated event.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.
Event or Problem Description
During a left sublingual gland excision and transoral excision of submental mass, the surgeon was cauterizing a vessel underneath the patient's tongue.The forceps arced and burnt the patient's lip.There was a delay in the procedure to tend to the burn, but there was no additional patient injury.

• Brand Name: OLSEN
• Common Device Name: ADSON BIPOLAR FORCEPS
• Manufacturer (Section D): OLSEN MEDICAL LLC; 3230 commerce center pl; louisville, ky
• MDR Report Key: 9900667
• Report Number: 3000719969-2020-00003
• Device Sequence Number: 13641332
• Product Code: GEI
• UDI-Device Identifier: 00841785102912
• UDI-Public: 00841785102912
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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 Expiration Date: 08/28/2024
• Device Model Number: 20-1080K
• Device Catalogue Number: 20-1080K
• Device Lot Number: 113883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1