MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE

Model Number 495NAC

Device Problem Misassembly by Users (3133)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 04/26/2022

Event Type  Injury  

Event Description

At the beginning of a hysterectomy procedure the surgeon noticed the light cable was not attached to the scope.The scope was attached and after the procedure in recovery a noticeable "blister looking "mark was discovered on patient's right thigh.Burn was assessed by plastic surgeon to be a "superficial burn" and recommended antibiotic ointment.

Manufacturer Narrative

The product has not been returned, therefore no evaluation has been completed.

Manufacturer Narrative

This supplemental report is to correct the product code from 'fcw' to 'oay'.This event is filed under internal complaint id (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE
• Type of Device: LIGHT CABLE
• 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
• MDR Report Key: 14626157
• MDR Text Key: 293537632
• Report Number: 9610617-2022-00078
• Device Sequence Number: 1
• Product Code: OAY
• UDI-Device Identifier: 04048551290705
• UDI-Public: 4048551290705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D240740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 495NAC
• Device Catalogue Number: 495NAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Female