MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT

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	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The previous reportability decision was reversed based on a retrospective review.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Light source being used with 5mm laparoscope and light cord to perform "scope" surgery of pelvis.Towards the end of the case, the light source unexpectantly became disconnected and burned a hole through the drapes.This resulted in 5mm diameter to patient's left chest.

• Brand Name: LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
• Common Device Name: LIGHT CABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 17262969
• Report Number: 1221826-2023-00152
• Device Sequence Number: 7911797
• 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: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 495ND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female
• Patient Race: Asian