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

Catalog Number	0233050090
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfg date: 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 lead was used during a case and flickered during the procedure.The customer further reported that the lead appeared to get hot with staff reported that they could smell burning.Please note no burn was reported in this event.
Additional Manufacturer Narrative
Alleged failure: the customer reported that the light lead was used during a case and flickered during the procedure.The customer further reported that the lead appeared to get hot with staff reported that they could smell burning.The customer changed it for the other lead which worked fine.Small delay in swapping out the lead the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be with the l10 light source for the blinking issue.The warning on the ifu states "the surface temperature near the scope adapter and at the tip of the scope can exceed 41 °c if the light source is operated at high levels of brightness for extended periods of time.The heated scope and adapter can cause burns to the patient, user, or combustible materials." the device manufacture date is not known.The product was returned for investigation and the failure mode was not confirmed and will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the light lead was used during a case and flickered during the procedure.The customer further reported that the lead appeared to get hot with staff reported that they could smell burning.Please note no burn was reported in this event.

• Brand Name: PKG,FIBEROPTIC UNIVERSAL 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: 7754653
• Report Number: 0002936485-2018-00569
• Device Sequence Number: 173853
• Product Code: FCW
• UDI-Device Identifier: 07613327051636
• UDI-Public: 07613327051636
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0233050090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1