MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE, 300 CM, Ø4.8 MM

Model Number	495TIP
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknow if the device will be returned to the manufacturing site for investigation.In the event the device returns and relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id: (b)(4), cross reference complaint id: (b)(4), cross reference complaint id: (b)(4), cross reference complaint id: (b)(4).This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported on january 06, 2025 the collar is falling off the light cable, there is no information that the event caused a harm or serious injury to patient, user or third.Cross reference mdr: 9610617-2025-00072, cross reference mdr: 9610617-2025-00073, cross reference mdr: 9610617-2025-00074, cross reference mdr: 9610617-2025-00075.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on february 3,2025.This information is reflected in section d9.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the cable was delivered to us without the knurled cap or the large, slotted nut that goes with it.No mechanical damage can be seen around the large, slotted nut's thread.Corrosion can be seen around the internal retaining screws, which may have been caused by residual moisture after the clinical treatment.Furthermore, there is a kink in the hose.It is possible that the kink in the hose was caused by mechanical overload.The outer silicone sheath is not damaged and is intact.It is possible that the outer slotted nut came loose by itself through use or a possible impact, and that this is why the cable could suddenly come loose.This event is filed under internal complaint id (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE, 300 CM, Ø4.8 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE, 300 CM, Ø4.8 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21299954
• Report Number: 9610617-2025-00070
• Device Sequence Number: 18441345
• Product Code: FCW
• UDI-Device Identifier: 04048551004401
• UDI-Public: 04048551004401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 495TIP
• Device Catalogue Number: 495TIP
• Device Lot Number: OM05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided; 03/25/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/10/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown