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

Model Number HAR36

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

The complaint device was not returned to stryker sustainability solutions and was discarded by the user facility.As the device was not returned to stryker sustainability solutions, evaluation was unable to be performed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to: ancillary equipment issues such as insufficient power delivery by the generator or handpiece, compromised handpiece functionality due to overuse or wear/damage.Min/max button damage that could prevent proper activation of the device.Generator delivers more energy than displayed settings that could adversely affect surrounding tissue.Generator delivers less energy than displayed settings that could cause an incomplete or inadequate seal.Shaft/rod subassembly damage that could impede functionality of the device.Membrane switch assembly damage (e.G.Trace break, torn circuit, corrosion under button cover).Improper cleaning of the device during clinical use leading to tissue accumulation between the blade and shaft that could reduce cutting ability.Improper connection of instrument to hand piece.User selects improper min settings on generator that could unintentionally deliver an unexpected amount of power to the device.User activates on max instead of min that could cause tissue damage.Improper usage of the device including off label usage with a generator other than gen11.Improper visual signal interpretation or perception causing the operator to incorrectly interpret generator feedback.Prolonged activation (in general or against solid surfaces), repeated use of instrument beyond intended use that could cause excessive heat applied to the surgical site.The instructions for use (ifu) state: "inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker if it is not in acceptable condition for the procedure." "attach the hand piece to the instrument by rotating the instrument onto the hand piece in a clockwise rotation as viewed from the distal end of the instrument (finger tight only)." "use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade.Note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.Note: hold only the gray hand piece and not the instrument handle while applying the torque wrench." the reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the harmonic scalpel was not sealing properly and the patient had to return to the or due to bleeding.Following return to the or, the patient's condition was fine.These are commonly used devices that are readily available.

• 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: 5606222
• MDR Text Key: 43586284
• Report Number: 0001056128-2016-00047
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133672
• 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: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• 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