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

Model Number 496U

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Type  Injury  

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 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
• Type of Device: ILLUMINATED URETER PROBE
• 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 90245-5017 ; 4242188201
• MDR Report Key: 8903789
• MDR Text Key: 154747265
• Report Number: 9610617-2019-00067
• Device Sequence Number: 1
• Product Code: FCS
• UDI-Device Identifier: 04048551169629
• UDI-Public: 4048551169629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 496U
• Device Catalogue Number: 496U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other