MAUDE Adverse Event Report: ZINNANTI SURGICAL DESIGN GROUP INC SMOKE EVAC FUSION HAND PIECE AND 4 INCH PROBE; ELECTROSURGICAL CUTTER/COAGULATOR

Model Number 13-1004

Device Problems Misassembled (1398); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

Electrosurgical hand piece and probe being used on elective breast surgery.The insulation was trimmed back on the probe connector end of this device to facilitate easier connection.This trimmed version of the insulation allowed a gap when the probe was not seated properly and completely.This allowed arcing of the energy to the patients skin causing a burn.The small area of burn was able to be excised as part of the surgery resulting in no lasting consequence.

Manufacturer Narrative

Please see attached report detailing the analysis of the problem and design change initiated and tested to prevent a future similar incident.(b)(4).

• Brand Name: SMOKE EVAC FUSION HAND PIECE AND 4 INCH PROBE
• Type of Device: ELECTROSURGICAL CUTTER/COAGULATOR
• Manufacturer (Section D): ZINNANTI SURGICAL DESIGN GROUP INC; 95b frederick street; santa cruz CA 95062 000
• Manufacturer Contact: william zinnanti ; 95b frederick street; santa cruz, CA 95062-0000 ; 7173798606
• MDR Report Key: 4088325
• MDR Text Key: 17630453
• Report Number: 3009881188-2014-00001
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 935947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2016
• Device Model Number: 13-1004
• Device Catalogue Number: 13-1004
• Device Lot Number: 052014
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR