MAUDE Adverse Event Report: V. MUELLER LOVE-GRUNENWALD PITUITARY RONGEUR FORCEPS

Model Number NL6147

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2021

Event Type  malfunction  

Event Description

Instrument broke during surgery and retrieved via c-arm.Fda safety report id# (b)(4).

• Brand Name: LOVE-GRUNENWALD PITUITARY RONGEUR FORCEPS
• Type of Device: RONGEUR
• Manufacturer (Section D): V. MUELLER ; franlin lakes NJ 07417 1880
• MDR Report Key: 11348077
• MDR Text Key: 232838661
• Report Number: MW5099486
• Device Sequence Number: 1
• Product Code: HTX
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL6147
• 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 Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 109