MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION LED LIGHT SOURCE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0220220000
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
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 product was returned for investigation and the reported failure mode was confirmed alleged failure: failure has occurs intermittently on this light source, recently installed the probable root cause/s could be a bad green led.Advise to send the led module back to vendor.Ncr179538 was created.The led module will return to vendor.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was loss of light.

• Brand Name: PKG, PRECISION LED 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16065427
• Report Number: 0002936485-2022-00808
• Device Sequence Number: 15124892
• Product Code: FCW
• UDI-Device Identifier: 07613327051322
• UDI-Public: 07613327051322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082813
• 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): 02/08/2023

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 Model Number: 0220220000
• Device Catalogue Number: 0220220000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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