MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., SAFELIGHT FIBER OPTIC CABLE CLEAR, 5MM X 10FT 3.05M; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0233050100
Medical Device Problem Codes	No Display/Image (1183); Optical Obstruction (3002)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2020
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 (image).
Additional Manufacturer Narrative
Alleged failure: de lichtkabels buigen na het verharde stuk.Hierdoor valt regelmatig het licht uit gedurende een procedure.Kabel licht vezels zijn aanzienlijk beschadigd na kort gebruik.The light cables bend after the paved area.As a result, the light regularly goes out during a procedure.Cable light fibers are significantly damaged after short use.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be unintentional variation in the manufacturing process for safelight adapters, which renders certain combinations of safelight cables and adapters more difficult to separate than others.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 that there was loss of light (image).

• Brand Name: PKG., SAFELIGHT FIBER OPTIC CABLE CLEAR, 5MM X 10FT 3.05M
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10248414
• Report Number: 0002936485-2020-00267
• Device Sequence Number: 3463920
• Product Code: FCW
• UDI-Device Identifier: 07613327051650
• UDI-Public: 07613327051650
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 0233050100
• Device Catalogue Number: 0233050100
• Device Lot Number: 28332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1