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

Model Number	495ND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that customers had several incidents involving the storz laparoscopic light cords, resulting in burns to the patient.The majority of these have been the result of the cord becoming disconnected from the camera on the laparoscope.Prior to august 2020, we had outsourced cords through a 3rd party.In august 2020 we began using new storz cords.It seems the new cords do not have enough threads at the point of connection.The new cords also provide greater light intensity, which may be contributing to the burns.The storz representative that services the hospital had been included in discussions regarding concerns.
Additional Manufacturer Narrative
This report is to correct the initial reporting number from 1221826-2023-00139 to the correct reporting number of 1221826-2023-00140.The previous reportability decision for this event was reversed based on a retrospective review.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
• Common Device Name: LT. CABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma 01507 ; GM 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma 01507 ; GM 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17210170
• Report Number: 1221826-2023-00139
• Device Sequence Number: 5440604
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 4048551168899
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXCEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 495ND
• Device Catalogue Number: 495ND
• 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: 12/23/2020
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown