MAUDE Adverse Event Report: KARL STORZ ENDOVISION FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM

Model Number	495NA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case # (b)(4).
Event or Problem Description
It was reported that during a hysteroscopy and iud removal procedure on april-30-2024, the cable was found detached from the scope and was laying on top of the patient.After the procedure was completed, a superficial burn was found on the patient's anterior side.A topical solution was administered to treat the superfical burn.The scope that was being used was a gynecare scope, not a karl storz scope.The cable will not be sent in for evaluation at this time per the customer.

• Brand Name: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 19477387
• Report Number: 2020550-2024-00160
• Device Sequence Number: 6932356
• Product Code: FCW
• UDI-Device Identifier: 04048551168868
• UDI-Public: 4048551168868
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2024
• Report Date (Section F): 05/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 495NA
• Device Catalogue Number: 495NA
• Device Lot Number: VU01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• 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 Age: 47 YR
• Patient Sex: Female