MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM

Model Number	495NE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Patient Problem/Medical Problem (2688)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it was reported by the facility being noted by the surgical team the patient had received a superficial burn approximately one inch in diameter, that appeared to most likely arise from the light source cord resting on the patient's abdomen, our ifu warns against resting of the light cable on the patient or drape.The facility has responded stating they used the wrong size of light cable with the size of the telescope.The customer does not know the manufacturing code, and will not return the cable for further evaluation.
Event or Problem Description
Per medwatch report 2200710000-2020-8042, at the end of a laparoscopic cholecystectomy when the or lights were turned on, it was noted by the surgical team the patient had received a superficial burn approximately one inch in diameter that appeared to most likely arise from the light source cord resting on the patient's abdomen.The light source cord at the telescope connection site intra op felt very hot to touch at the end of the procedure.The patients skin inured site/area was cleaned, bacitracin ointment applied, followed by adaptic, and dry sterile dressing.

• Brand Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM
• Common Device Name: LIGHT CABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen ; GM
• MDR Report Key: 10945159
• Report Number: 9610617-2020-00138
• Device Sequence Number: 558926
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 4048551168905
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: 495NE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 125