MAUDE Adverse Event Report: CAREFUSION (VMUELLER) CAREFUSION (VMUELLER); NERVE HOOK

Model Number NL3785-009

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

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

Event Date 10/04/2017

Event Type  malfunction  

Event Description

The tip of a carefusion (vmueller) nerve hook broke off while in use.

• Brand Name: CAREFUSION (VMUELLER)
• Type of Device: NERVE HOOK
• Manufacturer (Section D): CAREFUSION (VMUELLER); vernon hills IL 60061
• MDR Report Key: 6935761
• MDR Text Key: 89372061
• Report Number: MW5072664
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL3785-009
• Device Lot Number: 105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR