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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RAPTOR GRASPING DEVICE
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UNITED STATES ENDOSCOPY GROUP, INC. RAPTOR GRASPING DEVICE Back to Search Results
Model Number 00711177
Device Problems Device Inoperable (1663); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2015
Event Type  malfunction  
Manufacturer Narrative
The raptor grasping device is used to retrieve foreign bodies or resected tissue samples during endoscopic procedures of the upper and lower gastrointestinal and biliary tracts.The user facility reported that during an endoscopic procedure the raptor was being used to hold a guidewire as part of a push peg placement.While holding the jaws closed the technician heard a snap and the jaws of the device became inoperable in the open position and could not be pulled through the accessory channel of the endoscope.The endoscope was removed from the patient with the raptor grasping device in the accessory channel.The distal end of the device was cut and the device was removed from the endoscope.The procedure was completed using a second raptor grasping device.No injury to the patient or users was reported.During the investigation the user indicated "she was holding the jaws closed as tightly as she could when the break occured." review of the dhr for the device found that all in-process and final inspections were performed and acceptable results were documented.No other complaints have been received for devices from the same lot.The device involved in this event was returned and investigated.The distal end of the control wires were missing at the location of the cut the user made to remove the device; therefore no conclusion could be reached.The ifu includes the following warning and precautions: 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.Grasp the object gently while maintaining continuous traction.Do not use excessive force on the handle.
 
Event Description
The raptor grasping device is used to retrieve foreign bodies or resected tissue samples during endoscopic procedures of the upper and lower gastrointestinal and biliary tracts.The user facility reported that during an endoscopic procedure the raptor was being used to hold a guidewire as part of a push peg placement.While holding the jaws closed the technician heard a snap and the jaws of the device became inoperable in the open position and could not be pulled through the accessory channel of the endoscope.The endoscope was removed from the patient with the raptor grasping device in the accessory channel.The distal end of the device was cut and the device was removed from the endoscope.The procedure was completed using a second raptor grasping device.No injury to the patient or users was reported.
 
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Brand Name
RAPTOR GRASPING DEVICE
Type of Device
GRASPING DEVICE
Manufacturer (Section D)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd
mentor OH 44060
Manufacturer (Section G)
UNITED STATES ENDOSCOPY GROUP, INC.
5976 heisley rd
mentor OH 44060
Manufacturer Contact
michael oleksa
5976 heisley rd
mentor, OH 44060
4403586263
MDR Report Key5223722
MDR Text Key31474503
Report Number1528319-2015-00030
Device Sequence Number1
Product Code FGO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 11/12/2015
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
Device Operator Other
Device Expiration Date07/31/2017
Device Model Number00711177
Device Catalogue Number00711177
Device Lot Number1413511
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/15/2015
Initial Date FDA Received11/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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