MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05M; CONFOCAL OPTICAL IMAGING

Catalog Number	0233050300
Medical Device Problem Codes	Output Problem (3005); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the there was loss of light.
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.
Additional Manufacturer Narrative
Alleged failure: multiple issues with light cables and adapters.Cables work intermittently or not at all, adapters work intermittently or not at all.Update loss of light for 1-2 minutes.Likely 1-2 minutes to quickly troubleshoot and to get another light cable or adapter.Replacement device used to complete the procedure.] the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Probable root causes are: safelight bad adapters.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported the there was loss of light.

• Brand Name: PKG, AIM SAFELIGHT? FIBER OPTIC CABLE, 5.0MM X 10FT / 3.05M
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18163073
• Report Number: 0002936485-2023-01170
• Device Sequence Number: 7321383
• Product Code: OWN
• UDI-Device Identifier: 07613327051674
• UDI-Public: 07613327051674
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K142310
• 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): 07/02/2024

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: 0233050300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 07/02/2024
• 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