MAUDE Adverse Event Report: CAREFUSION 2200, INC. V.MUELLER DECKER RONGUER FORCEPS; RONGEUR

Model Number NL6250

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

During bilateral laminectomies at l4-l5; left medial facetectomy at l4-l5 and discectomy at l4-l5, decker neuro 2mm rongeur broke off into surgical field.Surgeon recovered tip with no resulting patient injury.Surgery completed.

• Brand Name: V.MUELLER DECKER RONGUER FORCEPS
• Type of Device: RONGEUR
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 4858581
• MDR Text Key: 18257306
• Report Number: 4858581
• 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: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NL6250
• Device Catalogue Number: NL6250
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2015
• Patient Sequence Number: 1
• Patient Age: 52 YR