MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG, X8000 LIGHT SOURCE; Light source, fiberoptic, routine

Catalog Number	0220200000
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hysteroscopic endometrial polypectomy combined with cervical polypectomy procedure under general anesthesia, the light source host unit of the laparoscopic system suddenly emitted an abnormal noise, followed by an interruption of light source output and complete loss of surgical field illumination, which directly compromised the ongoing surgical procedure.The surgical team immediately suspended the procedure and replaced the light source with a backup unit, restoring the surgical field illumination and allowing the surgery to proceed.The patient's vital signs remained stable throughout, and no adverse patient outcome was observed.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: PKG, X8000 LIGHT SOURCE
• Common Device Name: Light source, fiberoptic, routine
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 50897974
• Report Number: 0002936485-2026-01099
• Device Sequence Number: 6001060
• Product Code: FCW
• UDI-Device Identifier: 07613327051360
• UDI-Public: 07613327051360
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Catalogue Number: 0220200000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2016
• 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