MAUDE Adverse Event Report: US ENDOSCOPY RAPTOR; GRASPING DEVICE

Model Number	00711178
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via medsun report #(b)(4) that during a patient procedure their raptor grasping device - mini did not open once in the patient's airway.The procedure was completed successfully using a different device.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device was returned to steris for evaluation.A quality systems specialist tested the device and found that the jaws would not open when actuating the handle.The quality systems specialist opened the jaws manually by hand and then the jaws were able to open and close with the handle as expected.An exact cause could not be determined.It is unknown if the user facility tested that the device for proper operation prior to use as indicated in the instructions for use.The raptor grasping device - mini instructions for use states, "the following conditions may cause the device to function improperly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position, and actuating the device when the handle is at an acute angle in relation to the sheath.Do not use if the device is damaged or if the sterile barrier has been compromised.Save the device and packaging and contact your local steris endoscopy product specialist.Prior to use: 4.Visually inspect the device for damage.6.Actuate the device by moving the slider on the handle back and forth to confirm that the grasping jaws open and close smoothly.If the unit does not function properly, or there is evidence of damage (e.G.Bends, kinks, misshapen jaws, misaligned jaws, exposed wires) do not use this product and contact your local product specialist." the device history record for the subject lot was reviewed and confirmed the lot was manufactured according to specifications; no abnormalities were noted.A review of the complaint log confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: RAPTOR
• Common Device Name: 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 ; 4403586251
• MDR Report Key: 23727319
• Report Number: 1528319-2025-00110
• Device Sequence Number: 16100948
• Product Code: OCZ
• UDI-Device Identifier: 00724995183660
• UDI-Public: (01)00724995183660(11)250312(17)280312(10)12005653
• 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): 12/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00711178
• Device Catalogue Number: 00711178
• Device Lot Number: (10)12005653
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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