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

Model Number LF1744

Device Problem Energy Output Problem (1431)

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

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently in progress.The device has not yet been returned to stryker sustainability solutions for evaluation.A supplemental mdr will be submitted once the investigation is completed.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported that the customer had several damaged ligasure devices.There were error codes on the generator indicating an incomplete sealing cycle.Multiple attempts were made to obtain additional information from the complainant.The complainant was unable to provide specific event details.These are commonly used devices that are readily available.

Event Description

It was reported that the customer had several damaged ligasure devices.There were error codes on the generator indicating an incomplete sealing cycle.Multiple attempts were made to obtain additional information from the complainant.The complainant was unable to provide specific event details.These are commonly used devices that are readily available.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.Manual continuity tests were performed and a short was found between the two jaws when closed.The 7 spacer pads were inspected for damage and damage was found on all spacer pads.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: spacer pad damage.Ancillary equipment failure.Device activated in contact with pooling fluid.Device used on vessels thicker than 7 mm.Grasping on too much tissue or inappropriate tissue types or on staples.Tissue build up (eschar).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.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, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 10551394
• MDR Text Key: 207563514
• Report Number: 0001056128-2020-00072
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 07613327375800
• UDI-Public: 07613327375800
• Combination Product (y/n): N
• PMA/PMN Number: K180499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744RR
• Device Lot Number: 11139695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1