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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch mw5165926 that, "stasis disposable raptor grasping device needed for a case.Package opened and upon review, the cleaver did not work.Not sure if broken.Device not used and another raptor grasping device taken off shelf and functioning and then used in patient case." no report of injury.
Additional Manufacturer Narrative
The raptor grasping device subject of the reported event was requested for return and evaluation.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.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting an mdr solely due to the receipt of the user facility medwatch report which is in accordance with our policies and procedures.Investigation of this event is in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Steris requested the device for return and evaluation; however, the raptor grasping device subject of the reported event was not returned.Without the return and evaluation of the device a cause of the event cannot be determined.No additional issues have been reported.

• 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: 21712982
• Report Number: 1528319-2025-00023
• Device Sequence Number: 4514914
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: (01)00724995183653(11)241206(17)271206(10)11649796
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/27/2025

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)11649796
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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