MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE; Confocal Optical Imaging

Model Number	495NAC
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At the beginning of a hysterectomy procedure the surgeon noticed the light cable was not attached to the scope.The scope was attached and after the procedure in recovery a noticeable "blister looking "mark was discovered on patient's right thigh.Burn was assessed by plastic surgeon to be a "superficial burn" and recommended antibiotic ointment.
Additional Manufacturer Narrative
The product has not been returned, therefore no evaluation has been completed.
Additional Manufacturer Narrative
This supplemental report is to correct the product code from 'fcw' to 'oay'.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
It was determined that both the product code and 510(k) number associated with this device were incorrect and have since been updated.Therefore, a correction supplemental was submitted to accurately reflect the current product code and 510(k) information.This event is filed under internal complaint id (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE
• Common Device Name: Confocal Optical Imaging
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 14626157
• Report Number: 9610617-2022-00078
• Device Sequence Number: 11848818
• Product Code: OWN
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026
• 2 Devices were Involved in the Event: 1 2

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: 495NAC
• Device Catalogue Number: 495NAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 09/04/2026
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/05/2023; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female