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

Model Number	LF1837
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the ligasure was clamped down to cut and when they tried to release the jaws, the top jaw broke and went sideways.Multiple attempts were made to obtain additional information.No information was provided regarding patient injury, medical intervention, or extended procedure time reported.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, there was evidence of bio-burden on the device.The handle, blade trigger, button, shaft, and jaws appeared to be intact.The device has a stryker plug, the plug was inspected for damage, corrosion, and deformation and none were found.The jaws were semi shut with the blade bent and sticking out of the jaws.A trocar was attached to the device.The device was taken apart to inspect the mechanical movement inside the handle.No abnormalities were noticed.The jaws were taken apart to inspect the blade.The blade was still intact and had a bend to it.The jaw and handle functionality could not be tested due to the blade being jammed causing the jaws to malfunction.The device inspection and functional testing indicated that the complaint was partially confirmed for the reported failure mode.The device inspection indicated that the jaw open and close portion of the reported event was confirmed and the "cutting issues" and "plug in error" was not confirmed.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.The instructions for use (ifu) state: do not apply additional hand force to the lever during sealing to ensure proper function.If the lever cannot be unlatched following use, open the device by forcing the lever forward from the handle.The device will no longer function properly and must be discarded.Do not engage the cutting mechanism over clips, staples, or other metal objects as damage to the cutter may occur.To engage the cutting mechanism, pull the cutting trigger completely back toward the body of the instrument.If the cutting trigger does not automatically return to position, unlatch and open the lever to manually return the cutting trigger.Inspect the instrument jaws prior to cleaning to ensure the blade is not deployed.Use the appropriately sized trocar to allow for easy insertion and extraction of the instrument.Carefully insert and withdraw the instrument through the cannula to avoid damage to the device and/or injury to the patient.Close jaws using device lever before insertion/extraction in the trocar.Do not attempt to clean the instrument jaws by activating the instrument on wet gauze.Product damage may occur.Do not clean the instrument jaws with a scratch pad or other abrasives.The reported event will continue to be monitored through post-market surveillance.

• 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: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24011337
• Report Number: 0001056128-2026-00003
• Device Sequence Number: 18454225
• Product Code: NUJ
• UDI-Device Identifier: 07613327500844
• UDI-Public: 07613327500844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172856
• 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): 01/08/2026

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: LF1837
• Device Catalogue Number: LF1837
• Device Lot Number: 16599314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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