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 Codes	Inadequate or Insufficient Training (1643); 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 (b)(6) 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).
Additional Manufacturer Narrative
It was reported that the user burned his arm on the metal connector when disconnecting the scope from the stack system.According to the statement of karl storz uk this issue is caused by a use error.Within the ifu it is described that the product becomes hot during use.Therefore, a product failure can be excluded.Karl storz uk communicated with the customer and have sent them the relevant instructions for use highlighting the warnings.They have also offered to provide further training to the user to prevent this type of event from reoccurring.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
• 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
• MDR Report Key: 17452968
• Report Number: 9610617-2023-00201
• Device Sequence Number: 7270341
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 4048551288900
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 09/01/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown