MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE, 4.8MM X 3000MM; FIBER OPTIC LIGH CABLE

Model Number	495NE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We evaluated the light cable and found the light fiber quality is poor (the fibers are dark).The light cable has been 3rd party repaired; the metal of the proximal end connector has tool marks, and a non-karl storz circular bullseye marking/logo has been added to this connector; additionally, a non-karl storz strain relief has been added to the distal end connector.Our ifu warns against resting of the light cable on the patient or drape.The facility acknowledged to us that they were aware of this, and they attributed the incident to user error.
Event or Problem Description
Allegedly, prior to the start of a laparoscopic gastric sleeve procedure the active light cable was laid on the patient's abdomen, which caused a 3rd degree burns to the patient.Hospital considers the cause was user error.

• Brand Name: LIGHT CABLE, 4.8MM X 3000MM
• 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: 8933282
• Report Number: 9610617-2019-00068
• Device Sequence Number: 242961
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 4048551168905
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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: 495NE
• Device Catalogue Number: 495NE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• 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: 37 YR
• Patient Weight: 113