MAUDE Adverse Event Report: BOVIE MEDICAL JOHN WEISS; PRIVATE LABEL JOHN WEISS & SON'S CAUTERY LOW-TEMP FINE TIP

Catalog Number 0111122

Device Problem Failure to Discharge (1169)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

End user received device on an (b)(6) 2022.It is unknown how many times the products were shipped, or the storage and handling conditions during shipments.Customer states: the device is stored at 20c temperature at 20-25% humidity.The device failed to heat to required temperature.Only visual inspection during unpacking process was completed,but not documented.Intended procedure was removal of tumor close to the eye.Multiple devices were attempted to be used, but none were able to reach the desired temperature for the procedure.On (b)(6) 2022 - symmetry became aware the surgery was terminated due to low power of device.Customer was asked further questions and mdr trees and action items were updated (b)(6) 2022.Customer was contacted 4 separate occasions, but was unable to provide further information about the complaint case.Complaint could not be confirmed at this time.True root cause is unable to be determined with accuracy at this time.This is the first complaint of its kind for this part code.Based on the above information, no further actions are required and 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.

Event Description

The customer alleges that part code 01111122 is too weak in output.The surgery was terminated due to low power of device.

• Brand Name: JOHN WEISS
• Type of Device: PRIVATE LABEL JOHN WEISS & SON'S CAUTERY LOW-TEMP FINE TIP
• Manufacturer (Section D): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: andy ferrell ; 3034 owen drive; antioch, TN 37013 ; 6159645553
• MDR Report Key: 15563191
• MDR Text Key: 306433712
• Report Number: 3007208013-2022-00042
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K945493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 0111122
• Device Lot Number: 0220D
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1