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	11/20/2018
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.Upon removal of the first raptor device from the scope, the device was observed to be missing a jaw component.The user could not locate the detached component, and was unsure if the component was retained in the patient or became detached after device removal from the scope.Through follow up with the user facility, us endoscopy learned that the user attempted to withdraw the raptor with grasped stent through the accessory channel of the endoscope.This technique is contrary to the instructions for use, which directs "keeping the object secured in the grasping jaws, withdraw the object together with the endoscope from the patient.Do not retract the device and the object into the endoscope; this could cause damage to the endoscope and the device".The cause of the event is attributed to the user attempting to withdraw the raptor device and retrieved object through the accessory channel of the endoscope, which is contrary to the instructions for use.The procedure was completed using a second raptor device, while withdrawing the stent together with the endoscope, as directed in the instructions for use.The device history record was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with this lot.The device subject of this event was not returned to us endoscopy for evaluation.In-service training was completed on 11/21/2018; there have been no further issues reported since.
Event or Problem Description
The user facility reported the jaw component of a raptor grasping device became detached during a procedure to retrieve a plastic stent.The procedure was completed using a second raptor device, with no report of harm to the patient or user.

• 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: 8181566
• Report Number: 1528319-2018-00042
• Device Sequence Number: 2118900
• Product Code: OCZ
• UDI-Device Identifier: 00816765011317
• UDI-Public: (01)00816765011317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/19/2018

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: No Information
• Device Expiration Date: 08/16/2021
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: 1813494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1