MAUDE Adverse Event Report: BOVIE; OPTHALMIC BURR

Model Number	0010
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are still anticipating the return of the device.At this time the lot number and date of purchase is unknown.There has been a total of (b)(4) sold of this device since 2016 with 2 additional complaints recorded for similar occurrences.(0.19%).A follow up report will be submitted once the device has been evaluated.
Event or Problem Description
The customer alleged that the doctor attempted to use the device on a patient, but it stopped working seconds after the button was pushed.There was no delay in treatment and there was no harm to the patient.
Additional Manufacturer Narrative
Upon receiving the returned device, it was tested with the returned batteries and two other batteries that were found on site.The device functioned as intended and per product specifications using all batteries.- as a result the complaint could not be confirmed.The true root cause could not be determined based on the evaluation.The complaint rate for this issue is low and no further actions are required.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.

• Brand Name: BOVIE
• Common Device Name: OPTHALMIC BURR
• MDR Report Key: 12009162
• Report Number: 3007208013-2021-00019
• Device Sequence Number: 3800933
• Product Code: HOG
• UDI-Device Identifier: 10607151000100
• UDI-Public: 10607151000100
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K950520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 0010
• Device Catalogue Number: 0010
• Device Lot Number: 2020-06-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1