MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG L12 LED LIGHT SOURCE WITH AIM; CONFOCAL OPTICAL IMAGING

Catalog Number	0220240300
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the patient was burned with the light cord.It was a 1st degree burn, the size was smaller than a dime.The surgeon disconnected light cord from the scope early in the procedure and the light box turned off.At the end of the procedure the surgeon disconnected the light cord from the scope and put camera head and light cord on the drape.The tech noticed the distal end of light cord burned through the drape.After investigating further, the light cord burned through patient gown as well.
Additional Manufacturer Narrative
Alleged failure: patient burn with light cord.Surgeon disconnected light cord from the scope early in the procedure and the light box turned off.At the end of the procedure the surgeon disconnected the light cord from the scope and put camera head and light cord on the drape.The tech noticed the distal end of light cord burned through the drape.After investigating further, the light cord burned through patient gown as well.L12 sn# (b)(6).Safelight cord sn# (b)(6).1788 camera head sn# (b)(6).[update: 1st degree burn, smaller than a diam, medical intervention - bacitracin and gauze, issue with camera head - the light remained on after being unplugged from the endoscope ].The failure(s) identified in the investigation is consistent with the complaint record.Probable root causes: esst issue causing safelight failure.Replace receptacle board.Advise to re-calibrate unit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the patient was burned with the light cord.It was a 1st degree burn, the size was smaller than a dime.The surgeon disconnected light cord from the scope early in the procedure and the light box turned off.At the end of the procedure the surgeon disconnected the light cord from the scope and put camera head and light cord on the drape.The tech noticed the distal end of light cord burned through the drape.After investigating further, the light cord burned through patient gown as well.

• Brand Name: PKG L12 LED LIGHT SOURCE WITH AIM
• Common Device Name: CONFOCAL OPTICAL IMAGING
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22925182
• Report Number: 0002936485-2025-00744
• Device Sequence Number: 10354161
• Product Code: OWN
• UDI-Device Identifier: 07613327572124
• UDI-Public: 07613327572124
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/30/2025

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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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