MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA KARL STORZ LIGHTED URETERAL STENT; LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL

Lot Number PQ01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 01/29/2020

Event Type  Injury  

Event Description

Pt sustained burn to left thigh after ureteral lighted stents were taped to left thigh.The portable light box was used to connect the ureteral lighted stents.

• Brand Name: KARL STORZ LIGHTED URETERAL STENT
• Type of Device: LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA
• MDR Report Key: 9671523
• MDR Text Key: 177996142
• Report Number: MW5092762
• Device Sequence Number: 2
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: PQ01
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 11