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

Model Number	B12LT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.The facility stated the device is unable to be returned.As the device was not returned for evaluation, physical inspection of the device was unable to be performed.However, the complainant provided photographic evidence of the reported event that was evaluated.Therefore, the reported event is confirmed.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, activated electrosurgical instrument melts part of device, 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.Should the device become available for return, the investigation will be reopened.
Event or Problem Description
It was reported that when performing a thoracoscopic lung decort/vats and removing the size 12 trocar, the trocar sleeve broke into pieces.As reported, some pieces went inside of the patient.All pieces were retrieved except for pieces that were too small to see.There were no samples available for investigation.An x-ray was not used to locate the pieces and a larger incision was not made to retrieve the broken pieces.There was no other patient injury reported and there was no medical intervention or extended procedure time reported.These are commonly used devices that are readily available.

• 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: 21874663
• Report Number: 0001056128-2025-00036
• Device Sequence Number: 18072225
• Product Code: NLM
• UDI-Device Identifier: 00885825020897
• UDI-Public: 00885825020897
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: B12LT
• Device Catalogue Number: B12LT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/21/2025
• 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: Other
• Patient Sex: Unknown