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

Model Number LF4418

Device Problem Failure to Seal (4070)

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

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the device failed during trauma and required suturing to seal.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.Inspection of the received complaint device showed evidence of all 7 connector pads intact without being worn down past the acceptable criteria.The device plug, which was stryker branded, was inspected for damage, corrosion and deformation on both sides, and none were found.The device handle was inspected for functionality and showed evidence of being functional through the auditory signal occurring during handle engagement along with the handle disengaging as intended.The locking mechanism of the device handle engaged and disengaged as intended.The thumb activation button was tested for functionality and showed evidence of being functional through the tactile click heard when the button was engaged and the thumb activation button disengaged as intended.The trigger when tested fully engaged, and closes and opens as specified.While the jaws were fully closed, they were inspected and shown to be properly aligned.Manual continuity tests were performed and confirmed to be acceptable.The device was connected to the force triad generator to verify that the device can seal, coagulate, and cut on test medium (beef stomach).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 forced triad generator and there was no disruption in the connection to the device.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.Burst pressure testing was performed on porcine vessels (carotid arteries) to verify vessel sealing capability.A 6.54 mm outer diameter vessel was sealed using calipers (cal-069, cal date: (b)(6) 2023, cal due: (b)(6) 2024).The wall thickness of the carotid artery was measured using a wall thickness gauge (me-403, cal date: (b)(6) 2023, cal due: (b)(6) 2024), and measured to be (b)(4).Using the ashcroft accuracy pressure gauge (pg-333, cal date:(b)(6) 2023, cal due: (b)(6) 2024), seal burst occurred at pressures of 6.024 psi (side a), and 5.184 psi (side b).The results of the visual and functional investigations 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 causes are: - ancillary equipment failure - use error: grasping on to too much or inappropriate tissue types (i.E.Bone) or grasping on staples, etc.- environmental disturbance: tissue build-up, eschar.- use error: 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 pre-op inspection.Tissue sticking is inherent to the design of the device and can be minimized through cleaning of the jaws with wet gauze.The instructions for use (ifu) state: reprocessed ligasure impact without nano-coating, large jaw, open sealer/dividers (model lf4418) instructions for use (ifu): - the nano-coating featured on the original device is not present on this product.- 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.- remove any embedded tissue from blade track and jaw hinge area.- do not clean the instrument jaws with a scratch pad or other abrasives.Reprocessed ligasure impact without nano-coating, large jaw, open sealer/dividers (model lf4418) instructions for use (ifu): - 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.Reprocessed ligasure impact without nano-coating, large jaw, open sealer/dividers (model lf4418) instructions for use (ifu): - notice ¿ do not turn the rotation wheel when the lever is latched.Product damage may occur.- 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 - do not attempt to clean the instrument jaws by activating the instrument on wet gauze.Product damage may occur.- remove any embedded tissue from blade track and jaw hinge area.- do not clean the instrument jaws with a scratch pad or other abrasives.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the device failed during trauma and required suturing to seal.The complainant is not aware of any extended procedure time.These are commonly used devices that are readily available.

• 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: 18672665
• MDR Text Key: 334949648
• Report Number: 0001056128-2024-00024
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327417845
• UDI-Public: 07613327417845
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 03/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LF4418
• Device Catalogue Number: LF4418RR
• Device Lot Number: 15341614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• 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
• Patient Outcome(s): Required Intervention