MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY INSTRUMENTS PITUITARY RONGEUR

Model Number 57-2052

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  malfunction  

Event Description

Pituitary rongeur broke while being used in patient's back during procedure.Fda safety report id # (b)(4).

• Brand Name: SYMMETRY INSTRUMENTS PITUITARY RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.
• MDR Report Key: 10553299
• MDR Text Key: 207743070
• Report Number: MW5096744
• Device Sequence Number: 1
• Product Code: HAE
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 57-2052
• Device Catalogue Number: 57-2052
• Device Lot Number: (10)120318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 74 YR
• Patient Weight: 113