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

Model Number	00711177
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this event was not retained by the user facility for evaluation.Without a returned device, the cause of the problem could not be determined.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "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." steris endoscopy has requested that the distributor offer in-service training to the user facility.No further issues have been reported.
Event or Problem Description
The distributor reported that the control wire of a raptor grasping device broke during procedural use.The jaws of the device were left in an open position and it could not be withdrawn through the endoscope, requiring removal and replacement of the endoscope to complete the patient procedure.A procedural delay was reported as a result of this event.

• Brand Name: RAPTOR GRASPING DEVICE
• Common Device Name: GRASPING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 10101283
• Report Number: 1528319-2020-00014
• Device Sequence Number: 3636934
• Product Code: OCZ
• UDI-Device Identifier: 00816765011317
• UDI-Public: (01)00816765011317
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K120084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: 1914823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1