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

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

The user facility reported via medwatch report mw5151943 that during a patient procedure that their raptor grasping device was unable to retrieve the food bolus due to the device not being able to open and close properly.No report of injury.

Manufacturer Narrative

The reported medwatch mw5151943 did not provide a user facility name, address, phone number or email contact.Without the user facility's contact information, steris is unable to obtain additional information regarding the reported event.The raptor grasping device of the reported event is unavailable for evaluation due to the user facility not being able to be contacted.Without the return or inspection of the subject device, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: RAPTOR GRASPING DEVICE
• Type of Device: RAPTOR 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: 18943047
• MDR Text Key: 339086347
• Report Number: 1528319-2024-00019
• Device Sequence Number: 1
• Product Code: OCZ
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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