MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RAPTOR GRASPING DEVICE

Lot Number	2207753
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the jaws to their raptor grasping device would not reopen during a patient procedure.Another modality was utilized to complete the procedure with report of delay.No report of injury.
Additional Manufacturer Narrative
The device was returned to steris endoscopy for evaluation however, it was identified that only part of the raptor grasping device was returned.Without the return of the full device, a root cause could not be determined.The instructions for use packet (ifu 731747) provides the following information to the user, "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.Do not use excessive force on the handle and do not coil the catheter outside of the endoscope.Excessive force or coiling may damage the device or damage the endoscope and may result in accidental injury to the patient or clinician.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.Actuating the device when the handle is at an acute angle in relation to the sheath.".The device history record of the lot subject of the event was reviewed and no abnormalities were found.A 3-year complaint review indicates this to be an isolated event.A follow-up mdr shall be submitted should additional information become available.No additional issues have been reported.

• Brand Name: RAPTOR GRASPING DEVICE
• Common Device Name: GRASPING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19554915
• Report Number: 1528319-2024-00048
• Device Sequence Number: 6805873
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: 00724995183653
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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 Lot Number: 2207753
• 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: 05/20/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2022
• 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