MAUDE Adverse Event Report: KARL STORZ IMAGING IMAGE1 CONNECT MODULAR CCU; CAMERA CONTROL UNIT

Model Number	TC200US
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because the light source was turned on before the camera head was plugged into the tc200us ccu, when the camera was plugged in, the software overrode the light source standby mode and the light source went back to the previous setting of 100% light intensity.Although there was no patient impact, in this scenario had the light cable been in contact with the patient's body, a patient injury could have occurred.The issue of the light source standby mode being overridden when a camera is attached to the ccu was addressed with new software version 2.8.1.The software for this unit has been upgraded to version 2.8.1.
Event or Problem Description
Allegedly, during set up for a laparoscopy procedure, the light source, with a light cable connected, was in stand-by mode and the light cable was not connected to a scope.When the camera head was connected to the ts200us camera control unit (ccu) , the light source automatically went to previous setting of 100% light intensity and, because the light cable was not connected to a scope and it was in contact with the patient's drape, the drape was burned.There was no impact on patient.

• Brand Name: IMAGE1 CONNECT MODULAR CCU
• Common Device Name: CAMERA CONTROL UNIT
• Manufacturer (Section D): KARL STORZ IMAGING; 1 s. los carneros road; goleta CA 93117
• MDR Report Key: 7261844
• Report Number: 2027009-2018-00011
• Device Sequence Number: 11235389
• Product Code: FET
• UDI-Device Identifier: 04048551356586
• UDI-Public: 4048551356586
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160044
• 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): 01/10/2018

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: Physician
• Device Model Number: TC200US
• Device Catalogue Number: TC200US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1