MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; SINGLE-USE REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS

Model Number	HARH36
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the harmonics are showing generator error consistent with: relax pressure on blade, then tells to remove device from the patent.The generator shows no instrument uses remaining.The device will not do the initial set up with the generator.The device stops functioning.Customer had to clamp a large artery for extended time due to product failures and time to get a functioning device.There was no patient injury or medical intervention and extended procedure time reported was 20 minutes to replace the device.These are commonly used devices that are readily available.
Additional 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 teflon pad, handle and contact rings appear to be intact.The device was verified for proper mechanical functionality of the jaws and handle actuation.No mechanical issues or anomalies were detected.The scalpel was initially revealed a "no instrument uses remaining" error as expected due to previous clinical use.The device was reset by hitting the advanced hemostasis and min buttons simultaneously.After reset and connection to the g11 scalpel generator using the appropriate hand piece the scalpel was tested and failed the initial testing with a tighten assembly error followed by a replace instrument error.The device was disassembled to inspect the scalpel rod.A large gouge was revealed, and while stressing the cutting blade, a high crack was identified on the blade outside of the cutting area which subsequently broke as a result of contact with the shaft assembly.No damage to the shaft pin was observed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: mishandling damage subsequent to distribution from stryker's sustainability solutions jaws/blade subassembly damage or separation too much force or torque applied to instrument, or grasping/pulling incidental and prolonged activation against solid surfaces, such as bone, metal or plastic attempting to bend, sharpen, or otherwise alter the shape of the blade.The instructions for use (ifu) state: 1.Verify compatibility of all instruments and accessories prior to using this instrument.2.The hand piece is shipped non-sterile.It must be sterilized prior to each use according to the instructions for use supplied with the hand piece.Assembly 1.Using sterile technique, remove the instrument from the package.To avoid damage, do not flip the instrument into the sterile field.2.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).3.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.4.Note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.5.Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.6.Note: hold only the gray hand piece and not the instrument handle while applying the torque wrench.7.Close the trigger.Remove the torque wrench by sliding it off of the shaft.Do not dispose of the torque wrench until the procedure is completed.The torque wrench is used to remove the instrument from the hand piece following the procedure.Dispose of the torque wrench only after completing the procedure.8.Note: take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or off of the shaft.9.Note: take care to avoid injury from the blade tip while sliding the torque wrench onto or off of the shaft.Operation 1.Connect the assembled hand piece and instrument to the generator and turn the generator power on.Note: min is the only mode that can be adjusted.2.Select the desired minimum power level using the increase and decrease "buttons on the generator touchscreen.Note: the recommended minimum starting power level is level 3.For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a lower generator power level.The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type, pathology, and surgical technique.3.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.4.5.6.The blade is ultrasonically energized when either the foot switch pedal is depressed or one of the hand control buttons is depressed.Pressing the left foot pedal of the footswitch or the lower hand control button (min) on the instrument activates the selected minimum power level.Pressing the right foot pedal of the footswitch or upper hand control button (max) on the instrument activates the maximum power level.Pressing the advanced hemostasis button on the instrument activates the advanced hemostasis.Under default settings, advanced hemostasis is hand-activated only.Note: the "min" button can be re-assigned to advanced hemostasis by selecting "convert min to advanced hemostasis" on the gen11 "settings¿ screen.Once "convert min to advanced hemostasis" is selected, the advanced hemostasis button is disabled.Note: energy is not delivered in advanced hemostasis mode until the jaws are completely closed.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.Note: scratches on the blade may lead to premature blade failure.Avoid accidental contact with other instruments during use.Do not use any means other than the torque wrench to attach or detach the instrument from the hand piece.Close the clamp arm by closing the trigger, and insert the shaft through a trocar or incision.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.Note: keep clamp arm open when using the inside bottom of the blade for back cutting.Warning: do not use advanced hemostasis mode for procedures where energy application is desired prior to full closure of the jaws (e.G.Solid organs).Energy is not delivered in advanced hemostasis mode until the jaws are completely closed.Warning: 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.Warning: prolonged usage of advanced hemostasis mode may cause tissue pad damage.7.Close the clamp arm by closing the trigger and remove the shaft from the trocar or incision.Shaft rotation 1.The instrument¿s shaft can be rotated 360°to facilitate visualization and access to target tissue when dissecting, grasping, coagulating, and cutting.The reported event will continue to be monitored through post-market surveillance.

• Brand Name: NA
• Common Device Name: SINGLE-USE REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS
• Manufacturer (Section D): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER-ENDOSCOPY LAKELAND 5300; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 21599453
• Report Number: 0001056128-2025-00022
• Device Sequence Number: 15541179
• Product Code: NLQ
• UDI-Device Identifier: 07613327346251
• UDI-Public: 07613327346251
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K202554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: HARH36
• Device Lot Number: 15339569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown