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

Model Number B5LT

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2024

Event Type  Injury  

Event Description

It was reported the clear tip at the end of the complaint device broke off into the patient and, although the team did their did diligence in the or to look for it, it was not identified via ultrasound until after the patient left the or.It was additionally reported that the patient was brought back into the or a few days later to remove the piece during a second surgery.There was no other patient injury or medical intervention reported and the complainant is not aware of the extended procedure duration.These are commonly used devices that are readily available.

Manufacturer Narrative

The device was not returned to stryker sustainability solutions for evaluation.As the complaint device was not returned, a conclusive root cause could not be determined and the reported event could not be confirmed.No device information was reported and the customer did not report lot # or serial # information.Therefore, the device history record (dhr) was unable to be verified.The reported event could be attributed to: excessive force applied contact with hard object or other improper handling insufficient structural integrity shipping/handling damage or extreme conditions the instructions for use (ifu) state: - the reprocessed endoscopic trocars and sleeves have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.The bladeless trocars may be used with or without visualization for primary and secondary insertions.Warnings - these instruments are only intended for use by individuals with adequate training and familiarity with minimally invasive techniques.For further information about techniques, complications and hazards, consult the medical literature.- prior to use, read and follow the instructions of this insert as well as those of the instruments and accessories to be used during the procedure.Damage to the instrument can lead to patient injuries.Always inspect instrument carefully for overall integrity before use.Directions for use - inspect the instrument and package before opening.The contents of the package are sterile if the packaging has not been compromised.If the package is damaged or if it was opened and the instrument was not used, return the instrument and packaging to stryker sustainability solutions for resterilization by ethylene oxide (eto) gas.- 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.- the trocar can be assembled by inserting the obturator into the cannula sleeve until they lock securely together.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.

• Brand Name: NA
• Type of Device: 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: 19160764
• MDR Text Key: 340789859
• Report Number: 0001056128-2024-00040
• Device Sequence Number: 1
• Product Code: NLM
• UDI-Device Identifier: 00885825014193
• UDI-Public: 00885825014193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B5LT
• Device Catalogue Number: B5LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention