MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CARRIER,FIBER OPTIC LIGHT; LIGHT CARRIER

Model Number	R8587GF
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer has not responded to our attempts to gather further information.The item was received 6/20/19 and evaluation has not been completed at this time.
Event or Problem Description
Allegedly, during a procedure the fiber optic light carrier became hot, it over heated, and burned the patient's tongue.

• Brand Name: CARRIER,FIBER OPTIC LIGHT
• Common Device Name: LIGHT CARRIER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8725057
• Report Number: 9610617-2019-00056
• Device Sequence Number: 2004241
• Product Code: FCW
• UDI-Device Identifier: 04048551211274
• UDI-Public: 4048551211274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: No Information
• Device Model Number: R8587GF
• Device Lot Number: UU02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/21/2019
• 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