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

Model Number LF4200

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

It was reported that the ligasure impact "cutting blade would not release." the procedure was completed successfully without any delay.There was no medical treatment or intervention and no adverse consequences associated with this event.

Manufacturer Narrative

Additional information was received stating that the device was getting stuck on the patent's tissue during use.This did not lead to any adverse consequences.The complaint device was returned to stryker sustainability solutions (sss) for an evaluation.The device was received with a derailed blade, eschar build-up in the guiding slots, and visible biological material on the jaws; evidence that it was clinically used.The blade was able to be realigned into the guiding slots; therefore, functional testing could be performed.The jaw functionality was tested and confirmed to be acceptable as it was able to actuate, locked/unlock multiple times.While the jaws were in the locked position, they were inspected and found to be aligned.The blade trigger was tested and verified to maintain smooth movement and did not stick or derail when activated.The device was then confirmed to pass cut testing as it was able to successfully make three consecutive cuts without any bunching; fraying; incomplete or unclean cuts.The results of the investigation performed indicated that the jaws of the returned device were stuck in the closed position as the blade was dislocated from the guiding slots.The locked jaws and dislocated blade most likely resulted from grasping a greater amount of tissue than the device intended for and then attempting cut it.Therefore, the failure was determined to be a result of clinical technique.Stryker sustainability solutions' instructions for use states: ¿do not use this device on vessels in excess of 7mm in diameter.¿ ¿to ensure proper function, eliminate tension on the tissue while sealing and cutting.¿ ¿grasp the intended vessel and/or tissue in the center of the jaws.To avoid incomplete vessel sealing, do not grasp tissue beyond the electrode surface; do not place tissue in the jaw hinge.¿ ¿close the white movable handle until it clicks and latches in place.¿ ¿keep the instrument jaws clean.Build-up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.¿ ¿avoid overfilling the instrument jaws with tissue.This may damage the cutting mechanism or cause the blade to deploy outside of its guiding features, possibly resulting in difficulty opening the jaws or unintended injury to the user or patient.¿ ¿visually confirm that the jaws have reached the closed position prior to activating the cutter.Failure to do so may damage the cutting mechanism or cause the blade to deploy outside of its guiding features, possibly resulting in difficulty opening the jaws or unintended injury to the user or patient.¿ ¿prior to activating the cutter, confirm that the jaws are in the closed position.Spacing between jaws must be less than two millimeters.¿ the lot control sheet for the complaint device indicates that the device passed all applicable inspections and tests prior to release.This report is being filed as a malfunction due to sss being in a 2 year reporting cycle due to mdr report 0001056128-2013-00079 filed on (b)(4) 2013 where the blade derailed and locked on the patient's tissue and had to be cut off even though there was no patient injury reported in this event.The reported event is not occurring more frequently or with greater severity than is usual for the device.

• Brand Name: LIGASURE IMPACT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC
• 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 ; 5307 great oak drive; lakeland, FL 33815 ; 4807635300
• MDR Report Key: 3771030
• MDR Text Key: 19022745
• Report Number: 0001056128-2014-00052
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111600
• 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: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: LF4200
• Device Catalogue Number: LF4200RR
• Device Lot Number: 2753026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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