MAUDE Adverse Event Report: INTEGRA PA INC. YASARGIL SCS 7 124D

Catalog Number 310309

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer reports that during a vascular procedure the hinge screw which aligns blades became dislodged and fell into the patient.The screw was successfully retrieved and there was no patient injury.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for eval.An investigation has been initiated based on the reported info.

• Brand Name: YASARGIL SCS 7 124D
• Type of Device: NA
• Manufacturer (Section D): INTEGRA PA INC.; 589 davies drive; york PA 17402
• Manufacturer (Section G): MILTEX, INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise drive; 6099366828
• MDR Report Key: 3726580
• MDR Text Key: 4305138
• Report Number: 2523190-2014-00004
• Device Sequence Number: 1
• Product Code: HCH
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• 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