MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG L9000 LIGHT SOURCE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0220210000
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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
Alleged failure: cib david, onsite, shortage- went off 4 times in a case.Po wcb the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause is wear and tear.Poor air flow may affect ventilation of the light source unit.This may result on intermittent loss of light.Manufacture date is not known.
Event or Problem Description
It was reported that there was loss of light.

• Brand Name: PKG L9000 LIGHT SOURCE
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12374924
• Report Number: 0002936485-2021-00473
• Device Sequence Number: 3609673
• Product Code: FCW
• UDI-Device Identifier: 07613327051339
• UDI-Public: 07613327051339
• 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): 10/11/2021

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: 0220210000
• Device Catalogue Number: 0220210000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1