MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ULTRASONIC CURVED SHEARS; NLQ

Model Number FCS9

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 11/05/2013

Event Type  Injury  

Event Description

It was reported through a medwatch received from the (b)(4) that during a procedure using an ultrasonic scalpel the "patient was burned on her right breast." follow-up with the user facility confirmed the burn was minor.

Manufacturer Narrative

The complaint was not returned to stryker sustainability solutions (sss) for an evaluation.However, based on the information in the instructions for use (ifu), the distal tip may have become hot from prolonged activation and/or activation against a solid surface.Additionally, the facility¿s equipment (the hand piece used to connect the instrument to the generator and the generator itself) could not be evaluated.As the generator and hand piece work together to power the instrument, any failures of these pieces of equipment will result in the instrument not working properly.Sss's ifu states: ¿audible high-pitched tones, resonating from the blade or hand piece, are an abnormal condition and an indicator that the blade or hand piece is not operating properly.The tones may be an indicator that the hand piece is beyond its useful life or that the blade has not been attached properly, and may result in abnormally high shaft temperatures and user or patient injury.¿ ¿high temperature at the distal end of the shaft can occur due to blood and tissue buildup between the blade and shaft.¿ ¿during prolonged activation, the blade, the clamp arm, and the distal end of the shaft may become hot.¿ the device history record for the reported device indicates that the complaint device passed all applicable inspections and tests prior to release.Device not returned.

• Brand Name: ULTRASONIC CURVED SHEARS
• Type of Device: NLQ
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 5307 great oak drive; lakeland, FL 33815 ; 4807635300
• MDR Report Key: 3625570
• MDR Text Key: 4129725
• Report Number: 0001056128-2014-00016
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: FCS9
• Device Catalogue Number: FCS9RR
• Device Lot Number: 2187527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR