MAUDE Adverse Event Report: US ENDOSCOPY RAPTOR GRASPING DEVICE

Model Number RAPTOR 00711178

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Mini raptor grasping device was in use, the wire broke where the grasping claw is.No pt harm.

• Brand Name: RAPTOR GRASPING DEVICE
• Type of Device: RAPTOR GRASPING DEVICE
• Manufacturer (Section D): US ENDOSCOPY
• MDR Report Key: 5881891
• MDR Text Key: 52416081
• Report Number: MW5064116
• Device Sequence Number: 1
• Product Code: FGO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 08/12/2016

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: 01/31/2016
• Device Model Number: RAPTOR 00711178
• Device Lot Number: 1601235
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR