MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG L12 LED LIGHT SOURCE WITH AIM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0220240300
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staff plugged in a light cord to l12.Once plugged in, the cord was sitting on drape not plugged into any adapters etc.It was on and becoming hot.Burned / melted tiny hole in drape hole punch size.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the staff plugged in a light cord to l12.Once plugged in, the cord was sitting on drape not plugged into any adapters etc.It was on and becoming hot.Burned/melted tiny hole in drape hole punch size.
Additional Manufacturer Narrative
Alleged failure: staff plugged in light cord to l12 (safelight green cord sn: (b)(6) once plugged in, cord was sitting on drape not plugged into any adapters etc, it was on and becoming hot.Burned/melted tiny hole in drape hole punch size.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Probable root causes are: bad safelight cable.Ifu states: avoid touching the endoscope tip or the light cable tip to the patient, and never place them on top of the patient, as doing so may result in burns to the patient or user.In addition, never place the endoscope tip or the area where the light cable connects to the endoscope on the surgical drapes or other flammable material, as doing so may result in fire.Inspection inspect the light source before each use.If applicable, verify safelight functionality by following the instructions in the checking the esst feature section.If a problem relating to functionality or significant appearance degradation, such as but not limited to the following, is observed or suspected, discontinue use immediately and contact your stryker representative.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG L12 LED LIGHT SOURCE WITH AIM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22107710
• Report Number: 0002936485-2025-00490
• Device Sequence Number: 18196583
• Product Code: GCJ
• UDI-Device Identifier: 07613327572124
• UDI-Public: 07613327572124
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K230754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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 Catalogue Number: 0220240300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown