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.Four complaints describe incidents involving the storz laparoscopic light cords, who were 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.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 (b)(6) 2020, we had outsourced cords through a 3rd party.In (b)(6) 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.

• 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
• MDR Report Key: 17210174
• Report Number: 2020550-2023-00140
• Device Sequence Number: 17503043
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 4048551168899
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2023
• Report Date (Section F): 06/26/2023

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown