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

Model Number	LF4418
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the ligasure was difficult to unlock and had to be pulled to get it opened.As reported, the surgery was able to be completed with a different device.There was no patient injury or medical intervention and extended procedure time reported was five minutes.There was no patient injury, medical intervention, 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.It was reported the facility did not save the device.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: - grasping on to too much or inappropriate tissue types (i.E.Bone) or grasping on staples, etc.- jaw trigger (handle) activation mechanism is damaged.- tissue build-up, eschar the instructions for use (ifu) state: - do not overfill the jaws of the instrument with tissue.This may damage the cutting mechanism or cause the blade to deploy outside of its guiding features, possibly resulting in difficultly opening the jaws or unintended injury to the user or patient.- open the jaws by squeezing the handle until it unlocks, then push the handle completely forward.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.Updated section b5, executive summary.
Event or Problem Description
It was reported the ligasure was difficult to unlock and had to be pulled to get it opened.As reported, the surgery was able to be completed with the device.There was no patient injury, medical intervention, 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: 22709411
• Report Number: 0001056128-2025-00053
• Device Sequence Number: 13158030
• Product Code: NUJ
• UDI-Device Identifier: 07613327417845
• UDI-Public: 07613327417845
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K180451
• 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): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 16039704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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
• Patient Sex: Unknown