RAPTOR GRASPING DEVICE
Received Dec 27, 2023 · Event occurred Aug 12, 2023
Report 1528319-2023-00050 · MDR key 18400663
Device
Generic name
Raptor Grasping Device
Manufacturer
United States Endoscopy Group, Inc.Model number
00711177Catalog number
00711177
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED VIA MEDWATCH (B)(4), "WHILE ATTEMPTING TO REMOVE FOOD LODGED IN ESOPHAGUS WITH THE RAPTOR GRASPING DEVICE, THE WIRE CONNECTING THE GRASP BROKE. FOOD BOLUS WAS EVENTUALLY DISLODGED WITH ANOTHER PIECE OF EQUIPMENT." NO REPORT OF INJURY.
Additional Manufacturer Narrative
THE LOT NUMBER FOR THE RAPTOR GRASPING DEVICE SUBJECT OF THE REPORTED EVENT WAS NOT PROVIDED IN THE MEDWATCH (B)(4) REPORT. STERIS HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL EVENT INFORMATION FROM THE USER FACILITY HOWEVER, THE USER FACILITY HAS NOT RESPONDED. AS THE LOT NUMBER WAS NOT PROVIDED IN THE MEDWATCH REPORT AND THE RAPTOR GRASPING DEVICE WAS NOT RETURNED, A DEVICE HISTORY RECORD CANNOT BE REVIEWED AND A ROOT CAUSE CANNOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.