MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE LLETZ; LOOP ELECTRODE

Catalog Number	ES11R
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not being returned for evaluation, instead pictures were provided of the damaged product.Upon evaluating the pictures, there was extreme damage to electrode with warping on the corner post that holds the wire in place.The wire was snapped directly at the corner post.Root cause has been determined to be extreme force during use of the electrode.This is the only complaint that has been received for this issue with over (b)(4) in sales since 2016.This is an isolated event and no further actions are necessary.This can be seen as the final report.If additional information is received that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.
Event or Problem Description
During leep procedure the reusable loop electrode broke while using it to take a biopsy.As a result it took longer than usual to obtain the biopsy for the patient.There was no patient harm.

• Brand Name: BOVIE LLETZ
• Common Device Name: LOOP ELECTRODE
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater, fl
• MDR Report Key: 10185164
• Report Number: 3007208013-2020-00016
• Device Sequence Number: 11017991
• Product Code: GEI
• UDI-Device Identifier: 00607151002381
• UDI-Public: 607151002381
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K014201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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 Catalogue Number: ES11R
• Device Lot Number: 2018-09-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1