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	Break (1069); Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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).
Event or Problem Description
It was reported on february 12, 2025, during a laparoscopy procedure, the tip of the fiber optic light cable came off.No harm or injury to patient reported.No negative impact in state of health reported.Cross reference complaint id (b)(4).
Additional Manufacturer Narrative
The device was returned to our us facility on june 04, 2025.It will be forwarded to the manufacturing site for investigation.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: during inspection, it was determined that the large, slotted nut and the knurled sleeve are missing.The small, slotted nut is loose.The device-side connector shows normal signs of wear.A few individual optical fibers are broken, but this has no negative impact on light output.The sheathing of the light cable shows no visible damage.Mechanical damage to the optical light connection may be a possible cause for the sudden detachment of the light cable.The light cable coming loose on its own can be prevented by performing a function test on the moving components before each use and after each clinical reprocessing.No further measures will be taken.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: 21527771
• Report Number: 9610617-2025-00363
• Device Sequence Number: 9565230
• Product Code: FCW
• UDI-Device Identifier: 04048551004401
• UDI-Public: 04048551004401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/12/2026

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
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 01/07/2026
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/09/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown