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

Catalog Number	LF1937
Medical Device Problem Code	Continuous Firing (1123)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that reprocessed maryland ligasure was not turning off when not used.This required medical intervention.The complainant not aware of any other patient injury or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation as there was no facility or contact information on the medwatch form provided.As the device was not returned for evaluation, inspection was unable to be performed and a conclusive root cause could not be determined.Stryker procedures support(s) that the device was unlikely to have been released from stryker with the reported failure mode.The lot number reported could not be found in our system.The device was not returned to stryker sustainability solutions.Therefore, the device history record (dhr) was unable to be verified.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.Grasping on too much tissue or inappropriate tissue types or on staples.User does not inspect the packaging and device prior to use.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.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.Inspect packaging for damage.If damaged, do not use.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.
Event or Problem Description
It was reported that reprocessed maryland ligasure was not turning off when not used.This required medical intervention.The complainant not aware of any other patient injury or extended procedure time reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• 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: 20136089
• Report Number: 0001056128-2024-00084
• Device Sequence Number: 7221766
• Product Code: NUJ
• UDI-Device Identifier: 07613327504897
• UDI-Public: 07613327504897
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: LF1937
• Device Lot Number: 1516248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female