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	02/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility was contacted by us endoscopy but has declined to provide any information regarding the procedure aside from that there was no harm to the patient.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 the event was returned to us endoscopy for evaluation.Examination of the returned device revealed that, contrary to the initial report, no portion of the device appears to have detached during use.The drive wires of the device were bent in a manner which indicates the device damage was due to the application of excessive force by the user.The instructions for use include the following statements: "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.Apply continuous gentle traction while squeezing the slider toward the thumb ring.Do not use excessive force or coil the sheath outside of the endoscope.This may damage the device and render it inoperable.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." us endoscopy has offered in-service training on the use of the device.However, the user facility has declined.There have been no further issues reported.
Event or Problem Description
Reference user facility medwatch report #5084083.The user facility reported that a raptor grasping device broke during a procedure, necessitating retrieval of a portion or portions of the device.There were no injuries associated with the reported event.

• 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: 8484171
• Report Number: 1528319-2019-00015
• Device Sequence Number: 19447271
• Product Code: OCZ
• UDI-Device Identifier: 00816765011317
• UDI-Public: (01)00816765011317
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/04/2019

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: 12/25/2021
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: 1820710
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1