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 given additional details.The scope and light cable were not tagged for replacement so cannot be sent in.There was patient injury.Device was not returned to manufacturer.The event is filed under the internal karl storz complaint id: (b)(6).
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 information regarding the incident, but have not been give any more 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
• Manufacturer Contact: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17242742
• Report Number: 9610617-2023-00145
• Device Sequence Number: 15130575
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 4048551168905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/30/2023
• 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 Sex: Unknown