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 Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hysteroscopy and iud removal procedure on (b)(6) 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.
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).
Additional Manufacturer Narrative
Changes made from the initial report: ---updated the udi number in section d4.Per investigation by the manufacturing site: ---lot date code vu01 indicates that this this light cable was manufactured the week of 8/3/2015 and shipped on 11/2/2015 per sap.---evaluation cannot be performed due to light cable not being returned.This event is filed under internal case # (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 19477391
• Report Number: 1221826-2024-00160
• Device Sequence Number: 20566106
• Product Code: FCW
• UDI-Device Identifier: 04048551168868
• UDI-Public: 04048551168868
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/12/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female