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 Problem 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 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.

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
• 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
• MDR Report Key: 17452964
• MDR Text Key: 320330705
• Report Number: 2027009-2023-00201
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 4048551288900
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2023

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2023
• Date Report to Manufacturer: 08/03/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other