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

Model Number	495NE
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.We were notified a patient was burned using a 5mm scope and the 495ne light cable.We were told the surgeon demanded the largest size light cable even though it was recommended to use the smaller (495nd) light cable.We have requested further info from the customer regarding product, surgeon and more info regarding the incident, but have not been give additional details.The scope and light cable were not tagged for replacement so cannot be sent in.There was patient injury.In conclusion, the complaint is considered as reportable.Device was not returned to manufacturer.Internal karl storz complaint id: (b)(4).
Event or Problem Description
We were notified a patient was burned using a 5mm scope and the 495ne light cable.We were told the surgeon demanded the largest size light cable even though it was recommended to use the smaller (495nd) light cable.We have requested further info from the customer regarding product, surgeon and more info regarding the incident, but have not been give any additional details.The scope and light cable were not tagged for replacement so cannot be sent in.There was patient injury.

• Brand Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM
• Common Device Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17242744
• Report Number: 2020550-2023-00145
• Device Sequence Number: 20510282
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 4048551168905
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2023
• Report Date (Section F): 06/30/2023

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: 495NE
• Device Catalogue Number: 495NE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2023
• 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 Sex: Unknown