MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number	LF4418
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the ligasure misfired.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The investigation results confirm this incident no longer falls within mdr reportability requirements as it was determined it was not functional output ¿uol-06: loose / damaged components¿.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, there was evidence of excess bio-burden present on the device.The handle, blade trigger, button, shaft, and jaws appeared to be intact, the device plug was cut off and not returned with the device.The jaws were cleaned to inspect the spacer pads for damage and none was found.A plug was re-attached by splicing the wires back together.Thumb button feedback was acceptable as it was able to depress the pressure pad on the membrane switch and exhibited a tactile click, and the pressure pad disengaged when released.The handle functionality was tested and confirmed to be acceptable as the lever was able to actuate the jaws multiple times.The handle lever was returned to the start position and the jaws opened when released.An audible click was heard when the jaw lever engaged the click tab.While the jaws were in the locked position, they were inspected and found to be properly aligned.The blade trigger was tested and verified to maintain proper movement.Manual continuity tests was performed and passed with no issues.The device was connected to the force triad generator to verify that the device could seal, coagulate, and cut on the test medium (pork intestine).The device was recognized by the force triad generator and the default number of power bars was displayed (2).The instrument was energized while grasping a test medium, and 30 sample cuts were made without any errors during the test.The device inspection indicated that the complaint was not confirmed for the reported failure mode.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: ancillary equipment failure device not connected to covidien electrosurgical generator.Electrical connections damaged.Power outage.Device activated in contact with pooling fluid.Device used on vessels thicker than 7 mm.Grasping on too much tissue or inappropriate tissue types or on staples.Device not cleaned while in use per ifu guidance.Inadequate cleaning of device, higher than expected level of native soil.The instructions for use (ifu) state: use caution during surgical cases in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.).For best results, apply the seal to unaffected vasculature.Do not use this instrument on vessels in excess of 7 mm in diameter.- place the vessel or tissue in the center of the jaws.To avoid incomplete sealing, do not grasp tissue beyond the electrode surface; do not place tissue in the jaw hinge.Contact between an active instrument electrode and any metal object (hemostats, staples, clips, retractors, etc.) may increase current flow and may result in unintended surgical effects, such as an effect at an unintended site or insufficient energy deposition.Eliminate tension on the tissue while sealing and cutting to ensure proper function.Do not attempt to seal over clips or staples as incomplete seals/damage to the cutting blade will occur.Contact between an active electrode and any metal objects may result in alternate site burns or incomplete seals.A continuous tone sounds to indicate the activation of rf energy.When the activation cycle is complete, a two-pulsed seal-cycle-complete tone sounds and rf output ceases.The surgeon may inspect the seal before cutting the vessel or tissue.After inspecting the seal, the surgeon should create a second seal adjacent to the first seal before cutting, as described below.Keep the instrument jaws clean.Build-up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a sterile, wet gauze pad as needed.A tone with multiple pulses indicates that the seal cycle was not completed.Do not cut tissue until you have verified that there is an adequate seal.Use caution during surgical cases in which patients exhibit incompressible tissue.There may be limitations associated with effective use of the device in these situations.Although the jaws of the instrument will accommodate tissue greater than 15 mm thick, exceeding the tissue thickness limit of 15 mm could result in compromised seals.When an alert condition occurs, energy delivery stops.After the alert condition has been corrected, energy delivery will be immediately available.Alert situations.When an alert condition occurs, energy delivery stops, the generator produces a sequence of pulsed tones, and an alert will be displayed on the generator.Do not cut the vessel.The user should inspect the seal site and instrument before proceeding.After the alert condition has been corrected, energy delivery will be immediately available.Troubleshooting steps 1.Release the footswitch pedal or activation button, if still engaged.2.Open the instrument jaws and inspect for successful seal.3.Follow the suggested corrective actions on the generator screen, the generator quick reference card, or in the generator user¿s guide.4.If possible, reposition the instrument and regrasp tissue in a location that overlaps the previous seal, then reactivate the seal cycle.Reason for alert.Too little tissue between the jaws ¿ the user is grasping thin tissue or not enough tissue; open the jaws and confirm that sufficient amount of tissue is inside the jaws.If necessary, increase the thickness of tissue that is grasped and reactivate the seal cycle.Too much tissue between the jaws ¿ the user is grasping too much tissue; open the jaws, reduce the amount of tissue that is grasped, and reactivate the seal cycle.- activating on a metal object ¿ avoid grasping objects, such as staples, clips, or encapsulated sutures in the jaws of the instrument.Dirt jaws ¿ use a wet gauze pad to clean surfaces and edges of instrument jaws.Excess fluids in surgical field ¿ minimize or remove excess fluids from around the instrument jaws.Activation switch released before seal completes tone ¿ the footswitch or activation button was released before the seal cycle was complete.Maximum seal cycle time has been reached ¿ the system needs more time and energy to complete the seal cycle.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the ligasure misfired.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• 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: 22287877
• Report Number: 0001056128-2025-00042
• Device Sequence Number: 12992369
• Product Code: NUJ
• UDI-Device Identifier: 07613327417845
• UDI-Public: 07613327417845
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180451
• 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,Followup
• Report Date (Section B): 07/24/2025

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: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 16546611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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