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	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
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.
Event or Problem Description
It was reported that there was a burn to the drape.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: drape burn probable root cause: reed switch assembly malfunction use error the device manufacture date is not known.81.

• 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: 10210013
• Report Number: 0002936485-2020-00248
• Device Sequence Number: 11363734
• Product Code: FCW
• UDI-Device Identifier: 07613327051520
• UDI-Public: 07613327051520
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1