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

Model Number	LF4418
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.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: damaged blade or jaws.Damage due to shipping, handling conditions.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 overfill the jaws of the instrument with tissue.This may damage the cutting mechanism or cause the blade to deploy outside of its guiding features, possibly resulting in difficultly opening the jaws or unintended injury to the user or patient.Notice ¿ do not engage the cutting mechanism over sutures, clips, staples, or other metal objects as damage to the cutter may occur.Notice ¿ do not turn the rotation wheel when the lever is latched.Product damage may occur.Keep the instrument jaws clean.Build-up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a sterile, wet gauze pad as needed do not attempt to clean the instrument jaws by activating the instrument on wet gauze.Product damage may occur.Remove any embedded tissue from blade track and jaw hinge area.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.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that the blade on device popped out.It malfunctioned with an exposed blade.There was no patient injury or medical intervention and extended procedure time reported was five to ten 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: 19670253
• Report Number: 0001056128-2024-00076
• Device Sequence Number: 14255949
• 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
• Report Date (Section B): 07/03/2024

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: 07/11/2026
• Device Model Number: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 15088210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2023
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American