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

Model Number LF4418

Device Problem Mechanics Altered (2984)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It is unknown if the device failed to seal, reported an error message on the generator, or failed to cut.The surgeon stated the patient had more bleeding and sutures were required.Extended procedure time was to replace device and suture.These are commonly used devices that are readily available.

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.Rep stated all the devices discarded by staff.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.The reported event could be attributed to: incompatible software revision on generator.Ancillary equipment failure.Not fully seating device into console during initial connection.Grasping on too much tissue or inappropriate tissue types or on staples or tissue build up (eschar).Device not properly cleaned.Trigger button (activation button) not engaged throughout the entire seal cycle.Device activated in contact with pooling fluid.Device used on vessels thicker than 7 mm.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 two-pulsed 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.Remove any embedded tissue from blade track and jaw hinge area.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

• Brand Name: NA
• Type of Device: 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: 16572145
• MDR Text Key: 311572069
• Report Number: 0001056128-2023-00006
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327417845
• UDI-Public: 07613327417845
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LF4418
• Device Catalogue Number: LF4418RR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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