MAUDE Adverse Event Report: SYMMETRY SURGICAL, INC BOVIE; CAUTERY PENCIL

Catalog Number AA01

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018 it was communicated to symmetry surgical that this complaint was being canceled as the pencils are now working with no issues.The medical staff has deemed the inability to activate the devices as user error.However, as a result a delay in surgery still occurred.No further actions are required.This can be seen as the final report.If additional information is obtained that alleges the need for corrective actions or indicates a risk to patient safety, a follow-up report will be submitted.

Event Description

The customer alleged during a procedure, that the cauterizing pens were dying very quickly.They had to open seven pens during the procedure and the eighth one worked long enough to complete the surgery.As a result there was a delay in the procedure.There was no injury to the patient.

Event Description

The customer alleged during a procedure, that the cauterizing pens were dying very quickly.They had to open seven pens during the procedure and the eighth one worked long enough to complete the surgery.As a result there was a delay in the procedure.There was no injury to the patient.

Manufacturer Narrative

On 10/19/2018 it was communicated to symmetry surgical that this complaint was being canceled as the pencils are now working with no issues.The medical staff has deemed the inability to activate the devices as user error.However, as a result a delay in surgery still occurred.No further actions are required.This is a follow up report to remove the outcomes attributed to adverse event and to correct the manufacturing name.

• Brand Name: BOVIE
• Type of Device: CAUTERY PENCIL
• Manufacturer (Section D): SYMMETRY SURGICAL, INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7986619
• MDR Text Key: 126106191
• Report Number: 3007208013-2018-00023
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• PMA/PMN Number: 5. PMA/510(K
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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 Operator: Health Professional
• Device Catalogue Number: AA01
• Device Lot Number: 0618G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability