MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE; 230CM,03.5 MM

Model Number 495NA

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is on-going.Product has been returned for evaluation but has not been completed.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that an event with the 495na fiber optic cable.According to the information received, while using the light cable on a patient, the scope attached to the light cable overheated injuring the patient.Patient suffered what appeared to be thermal burn 1st degree.Per the facility the scope and light cable were used during the entire surgical procedure, approximately 5 hours.The patient suffered what appeared to be a thermal burn 1st degree.

Manufacturer Narrative

This report is to correct the produict code from fcw to the correct product code of oay.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Per manufacture: the product was not returned.According to the customer, the optic 7230aa (zc 200963352 mdr23-124 972991) with the 495na light cable mentioned here heated up considerably during the 5-hour operation and the patient suffered a 1st degree burn.The mentioned light cable was disposed of by the user and is not available for a more detailed investigation of the incident or will not be returned.For this reason, a more detailed investigation and root cause analysis cannot be performed.A possible cause for the strong heating of the optics and the 495na light cable used in combination here and the resulting burn of the patient may be the use of an off-brand light source, a light output set too high or contamination of the light connection on the optics side.Too little distance to the surrounding tissue can also cause a burn.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE
• Type of Device: 230CM,03.5 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17136878
• MDR Text Key: 317292161
• Report Number: 9610617-2023-00125
• Device Sequence Number: 1
• Product Code: OAY
• UDI-Device Identifier: 04048551168868
• UDI-Public: 4048551168868
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 495NA
• Device Catalogue Number: 495NA
• Device Lot Number: CG
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 09/29/2023; 09/29/2023
• Supplement Dates FDA Received: 09/29/2023; 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 7230AA
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 65 KG