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

Model Number	LF1923
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is currently in progress.The investigation results will be submitted in a supplemental mdr.
Event or Problem Description
It was reported there was concern over patient having hematoma 10-24 hours post surgery and concerns at that point with the sealing of the device.No device was saved because the device worked properly during the cases.The patient was brought back within the same day for evacuation of the hematoma.These are commonly used devices that are readily available.
Event or Problem Description
It was reported there was concern over patient having hematoma 10-24 hours post surgery and concerns at that point with the sealing of the device.No device was saved because the device worked properly during the cases.The patient was brought back within the same day for evacuation of the hematoma.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.No device was saved by the reporting facility as the device worked correctly during the case.As the device was returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot/serial number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - ancillary equipment failure.- 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.- device not cleaned while in use per ifu guidance.The instructions for use (ifu) state: - lf19xx devices are compatible with forcetriad sw v3.6-v4.0, vlft10gen sw v1.1 - v2.1.0.14 and v4.01.15.- 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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 12492912
• Report Number: 0001056128-2021-00055
• Device Sequence Number: 3349959
• Product Code: NUJ
• UDI-Device Identifier: 07613327504880
• UDI-Public: 07613327504880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: LF1923
• Device Catalogue Number: LF1923RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention