MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG C-MAC; LARYNGOSCOPE, NON-RIGID

Model Number 11302BDX

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

According to the rn, while the anesthesiologist attempted to use the 4mm storz flexible c-mac scope, the device malfunctioned.During this time, the patient was in the operating room under anesthesia for a thoracic procedure.An endoscopy cart was brought into the or and a new device was obtained.Manufacturer response for flexible intubation scope, (brand not provided) (per site reporter).The rep was notified and information regarding disposable scopes was provided.

• Brand Name: C-MAC
• Type of Device: LARYNGOSCOPE, NON-RIGID
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 11214168
• MDR Text Key: 228169890
• Report Number: 11214168
• Device Sequence Number: 1
• Product Code: CAL
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11302BDX
• Device Lot Number: SN29691
• 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: 01/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA