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

Model Number HARH36

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/15/2022

Event Type  Injury  

Event Description

It was reported that a harh36 was not sealing properly.It was reported that, due to bleeding, the surgeon had to go from laparoscopic to open procedure.An injury to the pulmonary vein was also reported.However, the surgeon stated this injury was not caused by the device in question.The complainant is not aware of any extended procedure time.These are commonly used devices that are readily available.

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use was identified.The device was verified for proper mechanical functionality of the jaws and handle actuation.No mechanical issues or anomalies were detected.The ability of the device to seal vessels was tested.At no time during the sealing process did the device stop working, produce an error code, or emit any adverse noise.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause(s) are: 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).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.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.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.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.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 15598269
• MDR Text Key: 301679557
• Report Number: 0001056128-2022-00034
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346251
• UDI-Public: 07613327346251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161693
• 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: 10/13/2022

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 Model Number: HARH36
• Device Catalogue Number: HARH36RR
• Device Lot Number: 14004531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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 Outcome(s): Required Intervention