MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC LIGHT SOURCE UNIT, LINE-POWERED; POWER LED 175, W/O ACC.

Model Number	20161420-1
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an event pertaining to a power led at townlands hospital where it reported that the user received a burn to their arm when disconnecting the scope from the light source because the metal connector touched their arm.The user received first aid treatment.No lasting effects of the burn injury.The pain was initially kept covered but otherwise managed with first aid.The product was not returned to the manufacturer.
Additional Manufacturer Narrative
The device won't be returned to the manufacturing site in germany.The british subsidiary stated they have communicated with the customer and have sent them the relevant instructions for use highlighting the warnings in paragraphs 3.8 and 5.5 already.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPIC LIGHT SOURCE UNIT, LINE-POWERED
• Common Device Name: POWER LED 175, W/O ACC.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17452964
• Report Number: 2027009-2023-00201
• Device Sequence Number: 7270338
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 4048551288900
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/03/2023
• Report Date (Section F): 08/03/2023

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: 20161420-1
• Device Catalogue Number: 20161420-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2023
• Date Report to Manufacturer: 08/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown