MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Model Number LF4318

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

The complaint device was not returned to stryker sustainability solutions.It was reported the staff did not save the device.As the device was not returned to stryker sustainability solutions, evaluation was unable to be performed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to: thumb trigger button (activation button) not engaged throughout the entire seal cycle.Electrical connections damaged.Use of insufficient power setting.Sealing of vessels greater than 7 mm thickness.The instructions for use (ifu) state: the lf4318 instrument is intended for use only with the covidien force triad energy platform.Use of this instrument with other covidien generators or with generators produced by other manufacturers may not result in the desired tissue effect, may result in injury to the patient or surgical team, or may cause damage to the instrument.Do not use the ligasure system unless properly trained to use it in the specific procedure being undertaken.Use of this equipment without such training may result in serious unintended patient injury.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.Select the appropriate bar setting to achieve the desired tissue effect.This setting may need to be adjusted during the procedure.One (1) green bar ¿ use on isolated or small tissue bundles.Two (2) green bars ¿ use with average tissue bundles.Three (3) green bars ¿ use on larger tissue bundles (this setting may slightly increase fusion times.) note: the system detects the connected ligasure instrument and sets the intensity setting to 2 bars in the display.If settings are entered in the ligasure touchscreen prior to connecting the ligasure instrument, these settings will be reset to 2 bars.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 can result in unintended surgical effects, such as an effect at an unintended site or insufficient energy disposition.Do not activate rf energy until the handle has been properly latched.Activating the device before this is done may result in improper sealing and may increase thermal spread to tissue outside the surgical site.Do not activate the instrument while in contact with or near other instruments, including cannulas.Localized burns to the patient or physician may occur.Do not attempt to seal over clips or staples as this may result in an incomplete seal.If the seal-cycle complete tone has not sounded, an optimal seal may not have been reached.Reactivate the rf energy until a seal-complete tone is heard.Open the jaws by pushing forward the white, movable handle.Grasp the intended vessel and/or tissue in the center of the jaws.Close the handle until it clicks and latches in place.Activate the instrument by either of the following methods: press and hold the purple activation button on the back of the instrument.Depress and hold the corresponding round, purple or orange pedal on the footswitch.A continuous tone sounds to indicate that the vessel or tissue is being sealed.When the activation cycle is complete, a double end tone sounds and the energy platform discontinues rf output.Release the purple activation button on the instrument, or the purple or orange foot pedal when the seal cycle is complete.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.Failure to overlap seals.Keep the instrument jaws clean.Build-up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaws surfaces and edges with a sterile, water or saline soaked gauze pad as needed.Do not clean instrument jaws with a scratch pad.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported the ligasure did not seal.The surgical site was sealed with suture and tie.There was no patient injury and extended procedure time reported was minimal.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 5673871
• MDR Text Key: 45755346
• Report Number: 0001056128-2016-00065
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150538
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LF4318
• Device Catalogue Number: LF4318RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2016
• 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