MAUDE Adverse Event Report: STRYKER-ENDOSCOPY LAKELAND 5300; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number	B5LT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the obturator blade was found to be fractured/splintered at the tip.The picture returned by the complainant reveals that the tip may have come in contact with a cautery piece of equipment.The missing fragments from the complaint device were not returned for investigation.The device inspection indicated that the complaint was confirmed for the reported failure mode.A review of the dhr could not be performed as the lot number was not reported.Stryker procedure(s) support(s) that the device was unlikely to have been released from stryker with the reported failure mode.The reported event could be attributed to: - excessive force applied - contact with hard object or other improper handling (contact with cautery instrument) - insufficient structural integrity - shipping/handling damage or extreme conditions post distribution from stryker's sustainability solutions.The instructions for use (ifu) state: - damage to the instrument can lead to patient injuries.Always inspect instrument carefully for overall integrity before use.- do not use excessive force.- careful handling of instruments is necessary to avoid damage or breakage.- inspect the instruments for any damage.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.- a comprehensive understanding of the principles and techniques involved in laser, electrosurgical, and ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the tip of the trocar broke off.As reported, the fractured piece broke off before use on the patient.The tip of the device was reported to not have broken off completely.

• Brand Name: NA
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• 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: 21568463
• Report Number: 0001056128-2025-00016
• Device Sequence Number: 20994476
• Product Code: NLM
• UDI-Device Identifier: 00885825014193
• UDI-Public: 00885825014193
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K201511
• 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): 03/10/2025

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: B5LT
• Device Catalogue Number: B5LT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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