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

Model Number	LF2019
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation as multiple attempts were made but unsuccessful.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: not plugged in completely to recognize bar code or plugged into incompatible console ancillary equipment failure device plugged into multiple generators.The instructions for use (ifu) state: open the pouch, remove the device and the card from the pouch.Electric shock hazard ¿ do not connect wet accessories to the ligasure system.Position instrument cords to avoid contact with the patient or other cords.Do not wrap cords around metal objects.This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.Examine all ligasure system and instrument connections before using.Improper connections may result in arcing, sparks, accessory malfunction, or unintended surgical effects.- inspect the instrument and cords for breaks, cracks, nicks, or other damage before use.Failure to observe this caution may result in injury or electrical shock to the patient or surgical team or cause damage to the instrument.If damaged, do not use.Confirm proper ligasure system settings before proceeding with surgery.Connect adaptors and accessories to the electrosurgical unit only when the unit is off or in standby mode.Failure to do so may result in injury or electrical shock to the patient or operating personnel.Use caution when handling the instrument between uses to avoid accidental activation of the ligasure system.Do not place the instrument on the patient or drapes when not in use.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 during a surgical case today two devices were not working as expected.Device did not recognize in generator, showing an error message that wouldn't allow any sealing to happen.There was no patient injury or medical intervention and extended procedure time reported was 30 minutes.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: 20064296
• Report Number: 0001056128-2024-00082
• Device Sequence Number: 8826522
• Product Code: NUJ
• UDI-Device Identifier: 07613327565317
• UDI-Public: 07613327565317
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K230255
• 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
• Report Date (Section B): 08/26/2024

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: LF2019
• Device Catalogue Number: LF2019
• Device Lot Number: 15380713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2024
• Initial Report FDA Received Date: 08/26/2024
• 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
• Patient Sex: Unknown