MAUDE Adverse Event Report: KARL STORZ ENDOVISION LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT; LT. CABLE

Model Number 495ND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.In a further complaint it was reported, that the light cable fell off scope and burned patient.Further it was reported that the light cable 495nd burned the hand of the doctor when he touched the cord after it was plugged in.The event is filed under internal karl storz complaint id: (b)(4).Please reference complaints (b)(4).

Event Description

It was reported that during a procedure a light cable fell off scope and burned patient.

• Brand Name: LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
• Type of Device: LT. CABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma 01507 ; GM 01507
• MDR Report Key: 17212953
• MDR Text Key: 317987544
• Report Number: 2020550-2023-00139
• Device Sequence Number: 1
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 4048551168899
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2023,06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 495ND
• Device Catalogue Number: 495ND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other