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

Model Number	2D5ST
Medical Device Problem Codes	Degraded (1153); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the case upon insertion, plastic fragments broke off the end of the trocar and entered the patient's abdomen.The 5 mm reprocessed trocar and introducer had pieces of the introducer splinter/fracture off while attempting to introduce it into the abdomen.As reported, most of the larger pieces were retrieved and there were some small ones that could not be obtained.There is a theoretical risk of foreign body reaction in the future.There was no other patient injury or medical intervention reported and the extended procedure time reported was 10 minutes to obtain all the pieces as well as introduce a new trocar.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device, the spring-loaded blade was able to deploy through the shield exposing the blade.The blade revealed fragments of the shield.Upon a higher magnification of the shield, the shield revealed deterioration, (material failure, wear) of the yellow obturator shield.The blade tip had fragments of the shield attached to it.The device inspection indicated that the complaint was confirmed for the reported failure mode.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.The reported event could be attributed to: excessive force applied.Contact with hard object or other improper handling.Insufficient structural integrity.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.

• 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: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 23834256
• Report Number: 0001056128-2025-00090
• Device Sequence Number: 12032179
• Product Code: NLM
• UDI-Device Identifier: 00885825017255
• UDI-Public: 00885825017255
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2D5ST
• Device Catalogue Number: 2D5ST
• Device Lot Number: 16977747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown