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

Model Number 711177

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

The user facility reported that the user tried to use the raptor grasping device however, it did not function properly.The jaws on the device would not close and got stuck on a stent as it was being removed.Another raptor grasping device was utilized, and the patient procedure was completed successfully.No report of injury.

Manufacturer Narrative

Investigation of this event is currently in process.The device subject of the reported event will be returned to us endoscopy for evaluation.A follow-up mdr will be submitted when additional information becomes available.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Statements in the instructions for use include, "actuate the device by moving the slider on the handle back and forth to confirm that the fasting jaws open and close smoothly.If the unit does not function properly, or there is evidence of damage (e.G.Bends, kinks, misshapen jaws, exposed wires,) do not use this product and contact your local product specialist.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.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.".

Manufacturer Narrative

The device was returned for evaluation.It was found that there were multiple curvatures in the spring sheath which could indicate the device was actuated in an extremely coiled position or the user attempted to pass or open the device in an extremely articulated endoscope.The function of the device was tested, and the device worked without issue.The jaws were able to open and close in multiple configurations.Based on the review of the returned device it was determined that the likely cause of the reported issue was customer handling.Steris offered in-service training on the proper use and operation of the raptor grasping device; however, the user facility declined.No additional issues have been reported.

• Brand Name: RAPTOR GRASPING DEVICE
• Type of Device: GRASPING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 16869866
• MDR Text Key: 314590105
• Report Number: 1528319-2023-00013
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: 00724995183653
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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: Health Professional
• Device Model Number: 711177
• Device Catalogue Number: 711177
• Device Lot Number: 4858318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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