MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM; CONFOCAL OPTICAL IMAGING

Catalog Number	0233050400
Medical Device Problem Codes	Electrical Power Problem (2925); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
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 loss of light.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker japan.The technical service report indicates: repair request details: symptoms.Lights turn on and off during surgery.Fault details: after inspecting this product, we found no defects such as broken wires in the light cable.Processing details: light intensity measurement and functionality check were carried out.Probable root cause: broken optical fibers, poor light cable alignment in jaw, residue on fiber tip, nonuniform light output, use error, intermittent electrical component contact in safelight circuit, reed switch assembly malfunction, magnet missing from safelight adapter, use error.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was loss of light.

• Brand Name: FG SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY 5 MM
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20241765
• Report Number: 0002936485-2024-00652
• Device Sequence Number: 20873864
• Product Code: OWN
• UDI-Device Identifier: 07613327462777
• UDI-Public: 07613327462777
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192292
• 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): 01/03/2025

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: 0233050400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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