MAUDE Adverse Event Report: Stryker-Endoscopy Lakeland 5300; Laparoscope, general & plastic surgery, reprocessed

Model Number	D12LT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trocar broke while using on patient.The complainant is not aware of any patient injury, medical intervention, or extended procedure time.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, only the cannula was returned for investigation.The cannula housing was separated in half at the adhesive line, with adhesive present.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.- shipping/handling damage or extreme conditions.The instructions for use (ifu) state: - prior to use, read and follow the instructions of this insert as well as those of the instruments to be used during the procedure.Damage to the instrument can lead to patient injuries.Always inspect instrument carefully for overall integrity before use.- keep the trocar straight relative to the cannula when inserting or removing.If the trocar is at an angle relative to the cannula, it can damage the cannula and result in desufflation.- do not use excessive force.- verify compatibility of all instruments before use to avoid complications during surgery.- become familiar with specific model of trocar and cannula prior to employing it in a surgical procedure to avoid damage to patient, to operator or to instrument.- careful handling of instruments is necessary to avoid damage or breakage.- care should be taken when removing instruments not to prematurely dislodge the cannula.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 ; +1(888)888-3433
• MDR Report Key: 50444280
• Report Number: 0001056128-2026-00063
• Device Sequence Number: 9780099
• Product Code: NLM
• UDI-Device Identifier: 00885825015596
• UDI-Public: (01)00885825015596(17)290109(10)17417496
• 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): 08/25/2026

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: D12LT
• Device Catalogue Number: D12LT
• Device Lot Number: 17417496
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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