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

Model Number	LF1837RR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.The complaint device was returned with the original stryker sustainability packaging but without the packaging tray.Upon visual inspection, there was bioburden on the tip of the device.Further inspection showed evidence of all 6 spacer pads intact without being worn down past the acceptable criteria.Visual inspection of the device jaws revealed that the jaw hinge was loose and slightly bent open on the right side of the device with the jaw hinge pin still intact.The device jaws were aligned when the jaws were closed as intended.Comparing the complaint device jaw to an engineering sample device jaw, the complaint jaw showed evidence of a missing distal plastic wire guide at the base of the device jaw hinge.The device plug, which is covidien branded, was inspected for corrosion, damage, and deformation on both sides and none were found.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: -grasping on to too much or inappropriate tissue types or staples -improperly forcing open the jaws of the device -attempting to remove the device from the trocar with the jaws in the open position -device damage to mechanisms during use, shipping damage the instructions for use (ifu) state: in case the instrument is accidently dropped on the floor, turn off the generator and unplug the instrument prior to discarding.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.Do not turn the rotation wheel when the lever is latched.Product damage may occur.Turn the rotation wheel on the instrument until the jaws are in the required position.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the end of the ligasure plastic piece broke off in patient, defective after a couple of burns.The complainant is not aware of any patient injury, medical intervention, or extended procedure time.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: 21599034
• Report Number: 0001056128-2025-00021
• Device Sequence Number: 8938827
• Product Code: NUJ
• UDI-Device Identifier: 07613327500844
• UDI-Public: 07613327500844
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/13/2025

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: LF1837RR
• Device Catalogue Number: LF1837RR
• Device Lot Number: 15355895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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