MAUDE Adverse Event Report: LIFE INSTRUMENT CORP.; RONGEUR

Model Number 832-0715-0

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 11/26/2014

Event Type  malfunction  

Event Description

During a l5 s1 laminectomy discectomy, a pituitary was handed to dr.He attempted to open the instrument while advancing into the back, and found that it would not open, he then handed it off as broken.The instrument was looked at, and it appeared broken.

• Type of Device: RONGEUR
• Manufacturer (Section D): LIFE INSTRUMENT CORP.; 91 french avenue; braintree MA 02184
• MDR Report Key: 4909929
• MDR Text Key: 21560231
• Report Number: 4909929
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 832-0715-0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR