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

Model Number	LF4418
Medical Device Problem Codes	Contamination (1120); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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 device was opened and inside were black dust specs that could not be identified.As reported, the device was opened before the case and the black particles were present inside before the device was opened.Because the packaging was opened before the sales representative was there, it was no possible to determine if this was something that had occurred during shipping.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 investigation results confirm this incident no longer falls within mdr reportability requirements as it was determined it was not functional output ¿uol-06: loose / damaged components¿.The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the complaint device was received open with the stryker sustainability packaging and tray.The handle, blade trigger, button, shaft, and jaws appeared to be intact.There was foreign material found on the device and inside the tray.The device was carefully taken apart to be inspected.Foreign material was found in the inside of the device.Ftir analysis was performed.The samples were positive for dried blood and ethylene glycol stearate.The device inspection indicated that the complaint was confirmed for the reported failure mode.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 conditions and/or handling post-distribution by stryker's sustainability solutions.The instructions for use (ifu) state: - inspect packaging for damage.If damaged, do not use.- package is provided sterile by method of ethylene oxide gas and is for single patient use only.Do not use if there is any evidence of damage to the package.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the ligasure device was opened and inside were black dust specs that could not be identified.As reported, the device was opened before the case and the black particles were present inside before the device was opened.Because the packaging was opened before the sales representative was there, it was not possible to determine if this was something that had occurred during shipping.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: 22240487
• Report Number: 0001056128-2025-00041
• Device Sequence Number: 13036236
• Product Code: NUJ
• UDI-Device Identifier: 07613327417845
• UDI-Public: 07613327417845
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 16668024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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