MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG.,FIBEROPTIC CABLE 5.0MM X 10 FT. (3.05M); LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0233050064
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
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 a burn to the drape.
Additional Manufacturer Narrative
Alleged failure: drape burn after use.Set down on drape and when they went to pick product up they noticed the cord burnt the drape salesforce case number (b)(4) the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s are: "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 product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacturer date is unknown.
Event or Problem Description
It was reported that there was a burn to the drape.

• Brand Name: PKG.,FIBEROPTIC CABLE 5.0MM X 10 FT. (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: 9931389
• Report Number: 0002936485-2020-00159
• Device Sequence Number: 19537515
• Product Code: FCW
• UDI-Device Identifier: 07613327051520
• UDI-Public: 07613327051520
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/13/2020

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: 0233050064
• Device Catalogue Number: 0233050064
• Device Lot Number: 152956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1