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

Device Problems Inadequate or Insufficient Training (1643); Human-Device Interface Problem (2949)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/11/2023

Event Type  Injury  

Event 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.

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).

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
• Type of Device: 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
• MDR Text Key: 320373138
• Report Number: 9610617-2023-00201
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 4048551288900
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other