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

Model Number LF1837

Device Problems Use of Device Problem (1670); Failure to Seal (4070)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported the device was taking longer than normal to cauterize.No information was provided regarding patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.As the complaint device was not returned, a conclusive root cause could not be determined and the reported event could not be confirmed.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: use error: thumb trigger button (activation button) not engaged throughout the entire seal cycle.Environmental disturbance: noise.Failure mode: active electrode short, electrical connections damaged.Failure mode: device not properly cleaned.Environmental disturbance: contamination of device in pre-op inspection.The instructions for use (ifu) state: sealer/divider without nano-coating (model lf1837) instructions for use (ifu): do not place the vessel and/or tissue in the jaw hinge.Place the vessel and/or tissue in the center of the jaws.Do not use this instrument on vessels larger than 7 mm in diameter.If the instrument shaft is visibly bent, discard and replace the instrument.A bent shaft may prevent the instrument from sealing or cutting properly.Eliminate tension on the tissue when sealing and cutting to ensure proper function.Use caution when grasping, manipulating, sealing, and dividing large tissue bundles.Do not attempt to seal or cut over clips or staples as incomplete seals will be formed.Contact between an active electrode and any metal objects may result in alternate site burns or incomplete seals.Do not activate the ligasure system until the lever has been latched.Activating the system before latching may result in improper sealing and may increase thermal spread to tissue outside of the surgical site.Prior to cutting the seal, inspect the vessel or tissue to ensure proper sealing.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.If the generator provides multiple power settings, use the lowest power needed to achieve the intended effect.Do not overfill the jaws of the instrument with tissue, as this may reduce device performance.Use caution during surgical procedures in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.).For best results, apply the seal to unaffected vasculature.Energy-based devices, such as es pencils or ultrasonic scalpels that are associated with thermal spread, should not be used to transect seals.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.H3 other text : 81.

Event Description

It was reported the device was taking longer than normal to cauterize.There was no patient injury or medical intervention and extended procedure time reported was a few minutes.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC,
• 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: 18378561
• MDR Text Key: 331374061
• Report Number: 0001056128-2023-00031
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172856
• 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,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: LF1837RR
• Device Lot Number: 15082558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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