MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ILLUMINATED URETER PROBE

Model Number	496U
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our local sales rep was informed that a patient received burns during a procedure while using illuminated ureter probes with a bifurcated fiber optic light cable.After multiple attempts, we have not been able to obtain any further details of this event.We suspect that the most likely cause of the burn injury was that the illuminated ureter probe connector that was connected to an active light cable, came into contact with the patient.Our ifu warns against attaching light cables to the patient or drape while the light source is on.The illuminated ureter probe was not returned for evaluation; however, our sales rep checked the ureter probe and light cord at the facility and everything appeared to be functioning normally.
Event or Problem Description
Allegedly, the patient sustained burns during a procedure.The customer believes the burns originated at the connections of the fiber optic illuminating ureter probes to the bifurcated fiber optic light cable, which were used during the procedure.

• Brand Name: ILLUMINATED URETER PROBE
• Common Device Name: ILLUMINATED URETER PROBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8903789
• Report Number: 9610617-2019-00067
• Device Sequence Number: 253272
• Product Code: FCS
• UDI-Device Identifier: 04048551169629
• UDI-Public: 4048551169629
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 496U
• Device Catalogue Number: 496U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/16/2019
• 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