MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number FCS9

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.It was stated the device was discarded at the user facility.As the device was not returned for evaluation, inspection/testing was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.All stryker sustainability solutions reprocessed devices are sold as sterile and are validated to a minimum sterility assurance level in accordance to applicable iso standards.When the sterile barrier of any device is opened, the sterility of that device becomes a function of handling and surgical technique and is beyond the control of stryker sustainability solutions.Therefore, the most likely root causes are device mishandling during preparation prior to procedure causing contamination of non-biological particles/debris on the device and/or non-sterile techniques used.The instructions for use (ifu) state: warnings and precautions: - the use of these instruments requires a thorough understanding of the techniques and principles of laser, electrosurgical, and ultrasonic procedures.Inappropriate use may result in shock and burn hazards to both patient and medical personnel or damage to the device or other medical instruments.Check and ensure electrical insulation or grounding is not compromised.Do not immerse instruments in liquid unless it is designed and stated.- high temperatures at the distal end of the shaft can occur due to blood and tissue buildup between the blade and shaft.Remove any visible tissue to prevent burn injury.- avoid incidental and prolonged activation against solid surfaces (such as bone), which may result in blade heating and/or blade failure.- when the instrument blade is activated the blade tip is active and will cut and coagulate tissue.Care must be taken to avoid unintentional contact between the blade surfaces and surrounding tissues.-verify hemostasis after withdrawing instrument.If bleeding is still observed, employ appropriate techniques to achieve hemostasis.Assembly: - remove the instrument from the package and place it in a sterile work area using aseptic technique.Should the device become available for return, the investigation will be reopened.The reported event will continue to be monitored through post-market surveillance.(b)(4).

Event Description

It was reported that a harmonic focus was used during a hemithyroidectomy.The initial procedure was completed successfully and upon discharge the patient was not prescribed antibiotics.Five days post-procedure the patient developed an infection and was admitted with a large abscess at the surgical site which required immediate incision and drainage.The patient spent time intubated in critical care and experienced jaw problems that she relates to being intubated for several days.There was no permanent impairment or damage reported and the patient's medical condition has since improved.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• 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 ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 6351295
• MDR Text Key: 68088797
• Report Number: 0001056128-2017-00039
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 00885825016012
• UDI-Public: (01)00885825016012
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FCS9
• Device Catalogue Number: FCS9RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 49 YR