MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; LED LIGHT SOURCE

Model Number TL300

Device Problems Thermal Decomposition of Device (1071); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

The storz light cord & scope was being used for procedure.It was a new power led light source 300.During the procedure, the light cord adaptor came apart from sterile scope part and the fiberoptic cord put 2 cigarette holes/burns through the sterile drapes at the patients right chest/ shoulder area.The patient was not harmed.Storz personnel who were on site went to the operating room to evaluate the cord and scope.

• Brand Name: N.A.
• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 11647961
• MDR Text Key: 244912418
• Report Number: 11647961
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TL300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9855 DA