RAPTOR
Received Feb 21, 2025 · Event occurred Jan 1, 2025
Report 1528319-2025-00009 · MDR key 21435870
Device
Generic name
Raptor Grasping Device
Manufacturer
Us EndoscopyModel number
00711177Catalog number
00711177
Lot number
(10)10614818
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FOLLOWING THE REPORTED EVENT, USER FACILITY PERSONNEL DISCARDED THE RAPTOR GRASPING DEVICE. WITHOUT THE RETURN OR EVALUATION OF THE DEVICE, A ROOT CAUSE CANNOT BE DETERMINED. STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION FOR THE RAPTOR GRASPING DEVICE HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
USER FACILITY PERSONNEL STATED THAT THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE RAPTOR GRASPING DEVICE. NO REPORT OF INJURY.
Description of Event or Problem
THE USER FACILITY REPORTED VIA MEDWATCH #(B)(4) THAT THEIR RAPTOR GRASPING DEVICE "DOES NOT CLOSE PROPERLY". NO REPORT OF INJURY.
Additional Manufacturer Narrative
STERIS HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HOWEVER, THE USER FACILITY HAS NOT RESPONDED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUBJECT LOT AND NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.