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

Model Number HARH45

Device Problem Energy Output Problem (1431)

Patient Problem Blood Loss (2597)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to stryker sustainability solutions for evaluation at this time.The investigation is currently in progress.Should the device become available for return, the investigation will include evaluation of the physical device.A supplemental mdr will be submitted once the investigation is completed.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported that the harmonic scalpel (harh45) did not properly seal one vessel and caused 1 liter of blood to be lost by the patient.The size of the vessel is unknown by the facility but was said to be one vessel that the surgeon always seals with the device.The facility contact is not aware of any further medical intervention.The extended procedure time reported was 10 minutes.These are commonly used devices that are readily available.

Event Description

It was reported that the harmonic scalpel (harh45) did not properly seal one vessel and caused 1 liter of blood to be lost by the patient.The size of the vessel is unknown by the facility but was said to be one vessel that the surgeon always seals with the device.The facility contact is not aware of any further medical intervention.The extended procedure time reported was 10 minutes.These are commonly used devices that are readily available.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.Visual inspection of the received complaint device revealed evidence of clinical use.The blade, jaw, teflon pad and contact rings appeared to be intact.Upon evaluation, the device passed functional testing.A review of the device history record (dhr) supports that the device met all inspections and test criteria prior to release from stryker.The reported event could be attributed to: ancillary equipment issues (e.G.Generator, handpiece, and/or adaptor).Applying improper or unnecessary directional or rotational force to connect instrument to hand piece.User expectation of adaptive tissue technology functionality.Improper usage and inadequate cleaning of instrument.User selects improper min settings on generator.Applying improper or inadequate directional force.The instructions for use (ifu) state: during benchtop testing of vessels >5 mm, the strongest vessel seals were achieved by allowing the advanced hemostasis mode to completely transect the targeted vessel.Caution: if activation is unintentionally stopped while sealing, maintain jaw closure and reactivate.Note: the generator provides an audible tone to indicate when the instrument blade is active.The generator changes to a second activation tone as adaptive tissue technology regulates the delivery of energy.Thermal influences such as fluids or minimal to no tissue in the jaws may affect the presence or timing of the tone change.The tone change does not provide confirmation of tissue effect.When the second tone is heard, the situation should be assessed and the intended surgical action completed, such as gradual application of tension to facilitate transection.The secondary activation tone change is not a substitute for surgical experience.The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the advanced hemostasis hand control button.Do not attempt to seal vessels in excess of 7 mm in diameter.If activation is unintentionally stopped while sealing, maintain jaw closure and reactivate.The instrument can be used for dissection, grasping, coagulation, and cutting between the blade and clamp arm.Note: to achieve complete sealing, the trigger should be fully closed and the vessel fully contained between clamp arm and blade of device.An audible and tactile "click" indicates full trigger closure.To achieve full closure of the jaws of the device, squeeze the plastic trigger until you feel it stop against the plastic handle (plastic to plastic) (illustration 9).If full trigger closure is released prior to or during activation on tissue, an audible and tactile "click" is evident.Increase grip force until full trigger closure is achieved.For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.Note: do not touch the instrument to metal while activated (illustration 6).Note: do not clean the blade tip with abrasives.It can be wiped with a moist gauze sponge to remove tissue, if necessary.If tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged (illustration 7).The max button is typically used for smaller vessels where cutting speed is fastest.The min button is typically used in slightly larger vessels and has reduced cutting speed.It is indicated for vessels up to 5 mm in size.The advanced hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in size.In this mode, cutting speed is further reduced and hemostasis is maximized.The instruments utilize adaptive tissue technology.This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate.While holding the hand piece in a vertical orientation, 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 (illustration 2).Use only the appropriate foot switch, hand piece, instruments, and power cord to ensure that they are compatible with the generator.The reported event will continue to be monitored through post-market surveillance.

Manufacturer Narrative

On 11/18/2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.

Event Description

It was reported that the harmonic scalpel (harh45) did not properly seal one vessel and caused 1 liter of blood to be lost by the patient.The size of the vessel is unknown by the facility but was said to be one vessel that the surgeon always seals with the device.The facility contact is not aware of any further medical intervention.The extended procedure time reported was 10 minutes.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; 5300 region ct; lakeland FL 33815
• MDR Report Key: 8719408
• MDR Text Key: 148765220
• Report Number: 0001056128-2019-00033
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346244
• UDI-Public: 07613327346244
• Combination Product (y/n): N
• PMA/PMN Number: K161693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2022
• Device Model Number: HARH45
• Device Catalogue Number: HARH45RR
• Device Lot Number: 9930237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/03/2019; 11/18/2020
• Supplement Dates FDA Received: 07/26/2019; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other