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

Model Number	LF4418
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ligasure had a bent prong.There was no 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.The returned complaint device was received with the stryker sustainability packaging box but without the packaging tray.Upon visual inspection, there was some evidence of bioburden present on the tip of the device.Further inspection showed evidence of all 6 spacer pads were intact without being worn down.The device plug, which was stryker branded, was inspected for damage, corrosion and deformation on both sides and showed evidence of the left prong bent inwards due to some sort of impact.The bent prong did not show any evidence of being loose.The results of the visual inspection determined that the reported event was confirmed.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root cause is handling conditions subsequent to distribution by stryker's sustainability solutions.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.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.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: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 19645861
• Report Number: 0001056128-2024-00072
• Device Sequence Number: 20470457
• Product Code: NUJ
• UDI-Device Identifier: 07613327417845
• UDI-Public: 07613327417845
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 07/01/2024

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: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 15382698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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