MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ADAPTER, RIGHT ANGLE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number	0331000400
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacture 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 a patient was burned.
Event or Problem Description
It was reported that a patient was burned.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient burn.Probable root cause: fan malfunction.Main board malfunction.Led module malfunction.Thermal switch malfunction.Use errors.Manufacture date is not known.(b)(4).

• Brand Name: PKG, ADAPTER, RIGHT ANGLE
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9293294
• Report Number: 0002936485-2019-00498
• Device Sequence Number: 10879677
• Product Code: FCW
• UDI-Device Identifier: 07613327057225
• UDI-Public: 07613327057225
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0331000400
• Device Lot Number: 17H5034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other