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

Model Number	D12LT
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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, a piece of rubber (valve/gasket) was returned.Upon comparison the lower cannula internal seal (valve), the gasket/seal/valve was torn.The detached piece of the torn gasket/seal/valve matched.Another tear was found on the seal as well.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: activated electrocautery instrument melts part of device, instrument is too large, physical obstruction of instrument insertion, gasket or seal folding in on itself.The instructions for use (ifu) state: warnings.Special care should be taken during insertion of bladed instruments so as not to damage the cannula valve, and/or seal resulting in desufflation of the operative cavity.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported a piece of the rubber valve broke off the trocar when an operating instrument was inserted through it.The piece ended up in the patient's abdominal cavity.As reported, the pieces were seen and then retrieved by the surgeon.The complainant is not aware of any patient injury and there was no medical intervention.Extended procedure time reported was "briefly (minutes)." 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: arsalan rizvi ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 24283908
• Report Number: 0001056128-2026-00010
• Device Sequence Number: 8319074
• Product Code: NLM
• UDI-Device Identifier: 00885825015596
• UDI-Public: 00885825015596
• 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): 02/06/2026

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: 17049324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• 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