MAUDE Adverse Event Report: WIGGINS MEDICAL PIT FENEST 2MM UPBITE 7 IN/RONGEUR 7" CERAMIC; PITUITARY RONGEUR

Model Number 52-097-20B

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

Patient Problem No Code Available (3191)

Event Date 02/26/2015

Event Type  Injury  

Event Description

Pituitary rongeur broke off in pt.Tip was recovered.Dates of use: 2007-2015.Event abated after use stopped or dose reduced: yes.Diagnosis or reason for use.

• Brand Name: PIT FENEST 2MM UPBITE 7 IN/RONGEUR 7" CERAMIC
• Type of Device: PITUITARY RONGEUR
• Manufacturer (Section D): WIGGINS MEDICAL; 2112 arendell way; tallahassee FL 32308
• MDR Report Key: 4616901
• MDR Text Key: 20785293
• Report Number: MW5041508
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2015

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?: No
• Device Operator: Other
• Device Model Number: 52-097-20B
• Device Lot Number: 06D188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 68