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

Model Number LF4418

Device Problems Energy Output Problem (1431); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported the device would either not heat or not retain heat.There was no patient injury or medical intervention reported, and no information was provided regarding extended procedure time.These are commonly used devices that are readily available.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported the device would either not heat or not retain heat.There was no patient injury or medical intervention and extended procedure time reported was less than ten minutes.These are commonly used devices that are readily available.

Manufacturer Narrative

The investigation results confirm this incident no longer falls within mdr reportability requirements as there was no spacer pad damage identified, no short circuit, and no sealing error displayed while grasping a test medium during testing.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, all 9 spacer pads intact without being worn down past the acceptable criteria, manual continuity was performed and confirmed to be acceptable.The device was recognized by the force triad generator and the default number of power bars were displayed (2).The plug was manually manipulated while plugged into the force triad generator.The instrument was energized while grasping the test medium until the force triad generator signaled that sealing/coagulation was complete and then automatically stopped energy delivery.The device was able to complete 30 cycles without emitting any error alerts or failing to work, and was able to seal/coagulate/cut as intended.No blade or jaw issues along with no out of the ordinary sticking to the test medium were observed during functional testing.The results of the visual and functional testing determined that the reported event was not confirmed.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: - use error: activation button (activation button) not engaged throughout the entire seal cycle - environmental disturbance: noise.- use error: device not cleaned while in use per ifu guidance.- environmental disturbance: contamination of device in preop inspection.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.- if the generator provides multiple power settings, use the lowest power needed to achieve the intended effect.- do not use this instrument on vessels in excess of 7 mm in diameter.- if the instrument shaft is visibly bent, discard and replace the instrument.- do not place the vessel and/or tissue in the jaw hinge.Place the vessel and/or tissue in the center of the jaws.- eliminate tension on the tissue while sealing and cutting to ensure proper function.- use caution when grasping, manipulating, sealing, and dividing large tissue bundles.- do not bend instrument shaft.- 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.- do not overfill the jaws of the instrument with tissue, as this may reduce device performance.- keep the instrument jaws clean.Build-up of eschar may reduce the seal and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.- the lever must be continually held with the activation button fully depressed until the seal cycle is complete.The lever does not latch into the activation position.- a continuous tone sounds to indicate the activation of rf energy.When the activation cycle is complete, a twopulsed seal-cycle-complete tone sounds and rf output ceases.- notice ¿ 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.- a tone with multiple pulses indicates that the seal cycle was not completed.Refer to the troubleshooting section for possible causes and corrective actions.Do not cut tissue until you have verified that there is an adequate seal.- to seal adjacent tissue, overlap the edge of the existing seal.The second seal should be distal to the first seal to increase seal margin.- activating energy delivery with a footswitch when the activation button is not fully depressed may result in improper sealing and increase thermal spread to tissue outside the surgical site.Proper pressure is being applied to the tissue when the lever keeps the activation button fully depressed.- energy-based devices, such as esu pencils or ultrasonic scalpels that are associated with thermal spread should not be used to transect seals.- failure to maintain steady pressure on the lever while cutting can result in inadvertent reactivation of energy.- wipe jaw surfaces and edges with a wet gauze pad as needed.- remove any embedded tissue from blade track and jaw hinge area.The reported event will continue to be monitored through post-market surveillance.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC,
• 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: 18480446
• MDR Text Key: 332902620
• Report Number: 0001056128-2024-00007
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF4418
• Device Catalogue Number: LF4418RR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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