MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE

Model Number	495NCSC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cable was not returned for evaluation; hospital is conducting their own investigation.Hospital reported that it took only five seconds for patient to receive burn after scope/camera/cable were laid on patient's bare skin.This leads us to believe that the light source was not put on standby before it was laid on the patient; we cannot confirm.We have this warning in our ifu: warning never place the end of a fiber optic light cable or telescope connected to a light cable on or under a surgical drape while the light source is activated.The intensity of the light source may cause burns to the patient and/or the surgical drape.Turn the light source to standby or initial mode when it is not in use.Karl storz recommends that the appropriate size light cable be used to minimize the heat energy generated from the light source.Use of appropriate size light cable will reduce the risk of patient burns, as well as the risk of igniting flammable material.Never attach a cable or cable connector to patient or drape.
Event or Problem Description
Allegedly, the doctor laid a scope which was connected to a camera and attached to an active light cable on the patient's bare skin; the patient received a burn.The hospital provided no further information.

• Brand Name: FIBER OPTIC LIGHT CABLE
• Common Device Name: FIBER OPTIC LIGHT CABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 6712536
• Report Number: 9610617-2017-00054
• Device Sequence Number: 16878186
• Product Code: FCW
• UDI-Device Identifier: 04048551290545
• UDI-Public: 4048551290545
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 495NCSC
• Device Catalogue Number: 495NCSC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 07/13/2017
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown