MAUDE Adverse Event Report: SYMMETRY SURGICAL GMBH SYMMETRY; FORCEPS, ENT

Model Number 63-6600

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

Thru-cut straight forceps was being used by surgeons.The tip of the forceps broke but was able to be retrieved.

• Brand Name: SYMMETRY
• Type of Device: FORCEPS, ENT
• Manufacturer (Section D): SYMMETRY SURGICAL GMBH; 3034 owen drive; antioch TN 37013
• MDR Report Key: 11472629
• MDR Text Key: 239424149
• Report Number: 11472629
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 63-6600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 117