MAUDE Adverse Event Report: APYX MEDICAL CORPORATION BOVIE DISPOSABLE HI TEMP VASECTOMY; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Model Number 66295

Device Problems Break (1069); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  malfunction  

Event Description

Bovie disposable hi temp vasectomy; imf 66295- had issue: wire separation from tip spontaneously during vasectomy yesterday as noticed by md "with heating up, the wire separated from the tip and was on vas- and was then removed (by md).There was no harm to the patient." per tech, "the wire appears to have broken evenly on both sides".

• Brand Name: BOVIE DISPOSABLE HI TEMP VASECTOMY
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): APYX MEDICAL CORPORATION
• MDR Report Key: 16352839
• MDR Text Key: 309379616
• Report Number: MW5114839
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2023

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
• Device Model Number: 66295
• Device Catalogue Number: AA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1