MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE, 3.5MM X 300CM; FIBER OPTIC LIGH CABLE

Model Number	495ND
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility states that their investigation found there was no problem found with the karl storz light cables or light sources used in the procedure, and that they concluded the cause of the patient burns was user error.Our ifu warns against attaching light cables to the patient or drape.The light cable was not returned for evaluation.
Event or Problem Description
Allegedly, during a breast procedure, two retractors with light cables attached were used; the doctor laid the retractors with light cables on the patient's chest, which caused second degree burns to the patient.Hospital considers the cause was user error and found no fault with the light cables or the light sources.

• Brand Name: LIGHT CABLE, 3.5MM X 300CM
• Common Device Name: FIBER OPTIC LIGH CABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8587688
• Report Number: 9610617-2019-00045
• Device Sequence Number: 16730871
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 4048551168899
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/26/2019

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: 495ND
• Device Catalogue Number: 495ND
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/07/2019
• 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