MAUDE Adverse Event Report: WIGGINS MEDICAL / EBNER MEDICAL LLC PITUITARY RONGEURS

Lot Number 52-096-20B

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2021

Event Type  malfunction  

Event Description

A pituitary instrument broke while dr.(b)(6) was using it in the pt.All parts retrieved.Fda safety report id# (b)(4).

• Brand Name: PITUITARY RONGEURS
• Type of Device: RONGEURS
• Manufacturer (Section D): WIGGINS MEDICAL / EBNER MEDICAL LLC; cincinnati OH 45206
• MDR Report Key: 12925011
• MDR Text Key: 281834334
• Report Number: MW5105760
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 52-096-20B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female