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

Model Number	LF1937
Medical Device Problem Codes	Use of Device Problem (1670); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
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 the device stopped working due to an issue with the jaws clamping and not releasing during the sealing process.There was no patient impact or medical intervention and the extended procedure time reported was minimal only to replace the device.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device the spacer pads were inspected for damage and all appeared to be in good shape.Manual continuity tests were performed and found an open connection on continuity on the plug prong #1 to bottom jaw.After the device failed to activate, it was carefully taken apart and inspected.All the internal components and wires were intact.Continuity was checked after the button activation circuit board connection where the the brown wire connects to the solder sleeve that connects the red wire into the bottom jaw.The connection was active before the solder sleeve connection.Continuity was verified after the solder sleeve and did not reveal an active connection.While dissecting the solder sleeve the red wire was not aligned with the solder ball and was protruding out.Manual continuity test revealed a disconnection coming from the brown/red solder sleeve connection.The results of the visual and functional inspections determined that the reported event was 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 most likely root cause of the reported event is improper installation of wire placement and soldering assembly during manufacturing, resulting in no activation/electrical error during clinical use.The instructions for use (ifu) state: - remove instrument from tray by firmly pulling on the handle.Do not pull on the instrument jaws or cable.- insert the connector into the receptacle on the generator.Follow the instructions in the generator user¿s guide to complete the setup procedure.- 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 us.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the device stopped working due to an issue with the jaws clamping and not releasing during the sealing process.There was no patient impact or medical intervention and the extended procedure time reported was minimal only to replace the device.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: 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: 18499045
• Report Number: 0001056128-2024-00010
• Device Sequence Number: 15422710
• Product Code: NUJ
• UDI-Device Identifier: 07613327504897
• UDI-Public: 07613327504897
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K180499
• 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): 02/20/2024

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 Expiration Date: 07/17/2026
• Device Model Number: LF1937
• Device Catalogue Number: LF1937RR
• Device Lot Number: 15103302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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