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

Model Number	LF1937
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device arrived visibly broken at the jaws with damage to the packaging.The complaint device was replaced and the procedure was reported to have been completed successfully.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported the device arrived visibly broken at the jaws with damage to the packaging.The complaint device was replaced and the procedure was reported to have been completed successfully.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 chipboard box was damages on the outside.Wrinkles and creases where seen on the corner and sides of the box.The packaging tray was damage on the corner.There was a crack exposing the device compromising the hermetic seal.The devices was damage at the tip.The jaw was bent and the grey plastic cover was separating form the jaw.The results of the investigation 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 was shipping/handling/storage damage subsequent to distribution from stryker.The instructions for use (ifu) state: inspect packaging before opening.The contents of the package are sterile if the package has not been compromised.Do not use the instrument if the sterility has been compromised.If the package is damaged or if it was opened and the instrument not used, return the instrument and the package to stryker.The contents of the package are provided sterile by method of ethylene oxide gas and is for single patient use only.Do not use if there is any evidence of damage to the package.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: 19028124
• Report Number: 0001056128-2024-00035
• Device Sequence Number: 18151678
• Product Code: NUJ
• UDI-Device Identifier: 07613327504897
• UDI-Public: 07613327504897
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/06/2024

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: 10/02/2026
• Device Model Number: LF1937
• Device Catalogue Number: LF1937RR
• Device Lot Number: 15309163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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