MAUDE Adverse Event Report: US ENDOSCOPY RAPTOR; RAPTOR GRASPING DEVICE

Model Number	00711177
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
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.
Event or Problem Description
User facility personnel stated that the patient procedure was completed successfully with the raptor grasping device.No report of injury.

• Brand Name: RAPTOR
• Common Device Name: RAPTOR GRASPING DEVICE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4404130648
• MDR Report Key: 21435870
• Report Number: 1528319-2025-00009
• Device Sequence Number: 14543006
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: (01)00724995183653(11)240621(17)270621(10)10614818
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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
• Operator of Device: Health Professional
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: (10)10614818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown