MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE ASSEMBLY, 4.8 MM X 2500 MM; FIBER OPTIC LIGHT CABLE

Model Number	495NCS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject light cable was not returned for evaluation.During our investigation we learned the 495ncs 4.8mm karl storz light cable was used with accurate surgical's retractor with suction, model assi.Abr36825 (which has a built-in light carrier), along with our 300w xenon light source.Customer did not record the light source's power setting; however, we learned they routinely set it to 100% light output.Our light source instructions recommend to always start with the lowest setting and that it should be used at the lowest setting necessary for providing adequate illumination.Although we cannot tell the size of the light carrier on the retractor, it appears that they should not have used the a 4.8mm light cable, but rather a smaller diameter light cable, such as our 495na 3.5mm light cable, which, per the hospital's report, they were aware of the correct size of cable to be used to minimize the heat energy generated from the light source.We also confirmed that the light carrier is not working properly; it is very dark, which most likely meant that some of its light fibers that transmit the light were broken and, thus, all the light could not be transmitted through the light carrier to the surgical site, becoming trapped at the connector.Light generates heat and, therefore, would heat up the connector to the light carrier.If the connector was in contact with patient's body, that would result in burns.Our ifu warns against laying active light cable on patient or drape.
Event or Problem Description
Allegedly, a patient undergoing a total mastectomy procedure sustained two burns, one second degree burn and one a third degree burn.

• Brand Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 2500 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8874337
• Report Number: 9610617-2019-00066
• Device Sequence Number: 14138844
• Product Code: FCW
• UDI-Device Identifier: 04048551001141
• UDI-Public: 4048551001141
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 495NCS
• Device Catalogue Number: 495NCS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2019
• 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
• Patient Age: 46 YR