MAUDE Adverse Event Report: CAREFUSION 2200, INC. KERRISON RONGEURS PITUITARY SET; RONGEUR, MANUAL

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

The tip of the micro pituitary broke off in patient.The top was able to be located with the help of the c-arm.Screw fell out of the kerrison-screw found.

• Brand Name: KERRISON RONGEURS PITUITARY SET
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 9957020
• MDR Text Key: 187531926
• Report Number: 9957020
• Device Sequence Number: 1
• Product Code: HAE
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1