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

Model Number 00711177

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Examination of the returned device found that one of the control wires was broken, resulting in the reported inability to close the jaws.Damage of this type can be attributed to the application of excessive force by the user.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 offered in-service training to the user facility; however, the facility has not responded.No further issues have been reported.

Event Description

The user facility reported that a raptor grasping device was damaged during procedural use.The jaws of the device were left in an open position and it could not be withdrawn through the endoscope, requiring removal of the endoscope to remove the device resulting in a procedure delay.The procedure was completed with another device and no harm to patient or user was reported.

• Brand Name: RAPTOR GRASPING DEVICE
• Type of Device: GRASPING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, oh
• MDR Report Key: 10290275
• MDR Text Key: 203862971
• Report Number: 1528319-2020-00022
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: (01)00724995183653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: 1917173
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1