MAUDE Adverse Event Report: US ENDOSCOPY RAPTOR; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	00711178
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Tried to use the mini raptor and it did not function appropriately.The jaws would not open and close, unable to grasp object to remove from patient.Tested outside of patient and was not able to open and close.

• Brand Name: RAPTOR
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 15995290
• Report Number: 15995290
• Device Sequence Number: 5950051
• Product Code: OCZ
• UDI-Device Identifier: 00724995183660
• UDI-Public: (01)00724995183660(17)20250811(11)20220812(10)2208902
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2022
• Report Date (Section F): 11/16/2022

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
• Operator of Device: Health Professional
• Device Model Number: 00711178
• Device Catalogue Number: 00711178
• Device Lot Number: 2208902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 11/16/2022