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

Model Number 00711178

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

User facility personnel stated that the raptor grasping device(s) were actuated prior to use and no issues were noted with the function or operation.The jaws opened and closed as expected.The raptor grasping device(s) subject of the reported event were sent back to steris endoscopy for evaluation.Evaluation results determined that following the removal of the patient's biomaterial from the devices, the raptor grasping device(s) operated properly.The jaws opened and closed with no issues.The device history record (dhr) for the subject lot was reviewed and confirmed the lot was manufactured to specification.A complaint review confirmed this to be an isolated event for the subject device.The instructions for use states, "actuate the device by moving the slider on the handle back and forth to confirm that the grasping jaws open and close smoothly.If the unit does not function properly, or there is evidence of damage (e.G.Bends, kinks, misshapen jaws, misaligned 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." 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.

Event Description

The user facility reported that during a patient procedure, an item was being retrieved from the patient's lung and the jaws on their raptor grasping device(s) would not open.User facility personnel elected to cancel the retrieval.The item was successfully retrieved during another procedure.No report of injury.

• Brand Name: RAPTOR GRASPING DEVICE-MINI
• Type of Device: RAPTOR GRASPING DEVICE-MINI
• 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: 18461118
• MDR Text Key: 332540283
• Report Number: 1528319-2024-00001
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00724995183660
• UDI-Public: 00724995183660
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00711178
• Device Catalogue Number: 00711178
• Device Lot Number: 7215773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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