MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CABLE, FIBEROPTIC NON TRANSPRT; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number	0233065010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the light cord cable was getting hot.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: light cable is hot.Broken optical fibers.Poor light cable alignment in jaw.Residue on fiber tip.Nonuniform light output.The device manufacturer date is not known.
Event or Problem Description
It was reported that the light cord cable was getting hot.

• Brand Name: CABLE, FIBEROPTIC NON TRANSPRT
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8519584
• Report Number: 0002936485-2019-00149
• Device Sequence Number: 19532529
• Product Code: FCW
• UDI-Device Identifier: 07613327051667
• UDI-Public: 07613327051667
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 0233065010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1