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

Model Number	496U
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The illuminated ureter probe was not returned for evaluation.Customer stated they cultured it and there was no growth on the cultured sample.
Event or Problem Description
Allegedly, after a procedure, blood/bodily fluid was noted inside of the ureter probe upon return for reprocessing, which could have possibly resulted in cross-contamination.

• 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: 8295086
• Report Number: 9610617-2019-00019
• Device Sequence Number: 1589498
• Product Code: FCS
• UDI-Device Identifier: 04048551169629
• UDI-Public: 4048551169629
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: 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: 10/25/2018
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1