MAUDE Adverse Event Report: GYRUS ACMI SUR-CATCH BASKET 3.0 FR (1 MM)

Model Number 5711008

Device Problems Material Separation (1562); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2014

Event Type  malfunction  

Event Description

Gyrus acmi sur-catch basket handpiece did not work and separated from wire.

• Brand Name: SUR-CATCH BASKET 3.0 FR (1 MM)
• Type of Device: SUR-CATCH BASKET
• Manufacturer (Section D): GYRUS ACMI; southborough MA 01772
• MDR Report Key: 3588946
• MDR Text Key: 15115014
• Report Number: MW5033931
• Device Sequence Number: 1
• Product Code: FFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/14/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 5711008
• Device Catalogue Number: 5711008
• Device Lot Number: MK778594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR