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

Catalog Number	0233050065
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
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 the cable heated causing a thermal event.This occurred prior to procedure.The procedure completed successfully.
Event or Problem Description
It was reported that the cable heated causing a thermal event.This occurred prior to procedure.The procedure completed successfully.
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: cable heating probable root cause: reed switch assembly malfunction, use error.Lot number is unknown; therefore, manufacture date can not be confirmed.

• Brand Name: PKG.,FIBEROPTIC CABLE 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: 8977143
• Report Number: 0002936485-2019-00377
• Device Sequence Number: 3275750
• Product Code: FCW
• UDI-Device Identifier: 07613327051537
• UDI-Public: 07613327051537
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 0233050065
• Device Lot Number: 129973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1