MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SINGLE FIBER OPTIC CABLE, PINK, 10 FT, ACMI; LIGHT, SURGICAL, FIBEROPTIC

Catalog Number	FC1SP
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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 there was a thermal event.
Additional Manufacturer Narrative
Alleged failure: nurse called said cord got hot during a procedure.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be that the portion of the cable where the broken light fibers are located, may have had pressure applied to this area by a heavy object.It is also possible that the concentrated area may have been wedged in between two hard surfaces causing the breakage of the fibers to occur, thus creating a hot spot on the cable.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a thermal event.

• Brand Name: SINGLE FIBER OPTIC CABLE, PINK, 10 FT, ACMI
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• 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: 21072928
• Report Number: 0002936485-2025-00014
• Device Sequence Number: 20929279
• Product Code: FST
• UDI-Device Identifier: 00816728020202
• UDI-Public: 00816728020202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090070
• 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): 04/17/2025

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: FC1SP
• Device Lot Number: 18111301
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/17/2025
• 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