MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG.FIBEROPTIC CABLE 5.0MM X 10 FT. 3.05M; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number	0233050064
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available, it will be provided in future reports.
Event or Problem Description
It was reported that the cable was burned during the procedure.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in japan.The technical service report indicates: we regret to inform you that the above-mentioned product cannot be repaired.Reason for non-repairability: the coating on this product is damaged (cut during surgery).However, since the components for this product are not supplied by the overseas manufacturer, we are unable to disassemble or replace parts for repair.Therefore, this product cannot be repaired.We would appreciate your kind consideration and understanding.Probable root cause: reed switch assembly malfunction use error the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the cable was burned during the procedure.

• Brand Name: PKG.FIBEROPTIC CABLE 5.0MM X 10 FT. 3.05M
• 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 ; 4087542000
• MDR Report Key: 23912049
• Report Number: 0002936485-2025-01026
• Device Sequence Number: 9148596
• Product Code: FCW
• UDI-Device Identifier: 07613327051520
• UDI-Public: 07613327051520
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 0233050064
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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