MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE KIT, X8000 LIGHTSOURCE, EUROPE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0220200000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
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 patient burn.
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: light cable; optics; leds; main board; jaw assembly; bent esst contact; inconsistent esst contact; cable pull out; camera head; firewire cable; software; front board; power supply; thermal switch; ac inlet board; ac inlet filter; touch screen; workmanship; inadequate air flow; inadequate calibration; excessive lint buildup inside the unit; use errors.The device manufacturer date is not known.
Event or Problem Description
It was reported that there was a patient burn.

• Brand Name: KIT, X8000 LIGHTSOURCE, EUROPE
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10544021
• Report Number: 0002936485-2020-00387
• Device Sequence Number: 3546208
• Product Code: FCW
• UDI-Device Identifier: 07613327051360
• UDI-Public: 07613327051360
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961971
• 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): 11/17/2020

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 Model Number: 0220200000
• Device Catalogue Number: 0220200000E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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