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	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The disposable raptor grasping device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.The stent was confirmed to be in the correct position after the raptor was released; no further intervention was required.The lot number of the device subject of this complaint was unknown and the device was not returned to us endoscopy for evaluation.The instructions for use include the following statements: "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." us endoscopy has offered in-service training to the user facility and the facility response is pending.
Event or Problem Description
The user facility reported during a stent positioning procedure, the raptor grasping device failed to release from the stent.The user facility cut the handle from the raptor device to free the stent and the procedure was completed.There was no report of harm to the patient or user.
Additional Manufacturer Narrative
Subsequent to initial report, the user facility has declined the offer of in-service training on the usage of this device.

• Brand Name: RAPTOR GRASPING DEVICE
• Common Device Name: GRASPING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7833903
• Report Number: 1528319-2018-00026
• Device Sequence Number: 1445460
• Product Code: OCZ
• UDI-Device Identifier: 00816765011317
• UDI-Public: (01)00816765011317
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1