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 11/10/2021

Event Type  Injury  

Event Description

At the start of a hysterectomy procedure with dilation and curettage, the light cable was noticed not to be connected to the scope but laid on the drape.A burn hole was found on the drape which had burned through to the patient's skin on right inner thigh.

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: 14576496
• MDR Text Key: 293258554
• Report Number: 9610617-2022-00081
• 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

• 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
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• 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: 40 YR
• Patient Sex: Female