MAUDE Adverse Event Report: ELLIQUENCE LLC GRASPING FORCEPS

Model Number DFX-G

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2014

Event Type  malfunction  

Event Description

On wednesday, (b)(6) 2014, a lumber discectomy procedure was performed.Grasping forceps were used to remove/debulk nucleus pulposus material from the inter-vertebral disc.During the use of the grasping forceps, the lower jaw of the biting cup detached from the instrument and remained in the pt.The surgeon was unable to remove the fragment during the initial surgery, but the fragment wsa removed during a subsequent surgery with no adverse issues to the pt.Elliquence received verbal confirmation of the incident on wednesday (b)(6) 2014.The grasping forceps was sent to the supplier for full investigation and root cause analysis.The supplier's report will help to determine the appropriate steps needed in order to close this event.

• Brand Name: GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): ELLIQUENCE LLC; 2455 grand avenue; baldwin NY 11510 000
• Manufacturer Contact: paul buhrke ; 2455 grand avenue; baldwin, NY 11510-0000 ; 5162779010
• MDR Report Key: 4118845
• MDR Text Key: 4702307
• Report Number: 3007024186-2014-00001
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFX-G
• Device Catalogue Number: DFX-G
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Distributor Facility Aware Date: 08/25/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2014
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization