MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE; LIGHT CABLE BIFURCATED AT TELESCOPE END 3.5 X 300CM

Model Number	495UDL
Medical Device Problem Codes	Temperature Problem (3022); Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were described with karl storz brand name but without model number and there is no contact information for us to follow up with the customer.We suspect they were our light cable item 495udl (bifurcated fiber optic, cable) connected to the ureteral probe 496u (ureter probe illuminated) and to the integra luxtec portable light source.We suspect the light cable and probe connector was in contact with the patient's thigh and resulted in the burn, we therefore file this event on the light cable.Our ifu 97000213 v3.0 (11-2017) warns the user not to rest the light cable on the patient for risk of injury.
Event or Problem Description
We received medwatch report mw5092762, it stated a patient sustained a burn on the left thigh after ureteral lighted stents connected to a portable light box were taped to the thigh.

• Brand Name: FIBER OPTIC LIGHT CABLE
• Common Device Name: LIGHT CABLE BIFURCATED AT TELESCOPE END 3.5 X 300CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9835664
• Report Number: 9610617-2020-00035
• Device Sequence Number: 11150811
• Product Code: FCW
• UDI-Device Identifier: 04048551169315
• UDI-Public: 4048551169315
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 495UDL
• Device Catalogue Number: 495UDL
• Device Lot Number: ZT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/16/2020
• 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: Required Intervention