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

Model Number 00711178

Device Problem Difficult to Open or Close (2921)

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

Event Date 11/08/2022

Event Type  malfunction  

Event 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
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 15995290
• MDR Text Key: 305607871
• Report Number: 15995290
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00724995183660
• UDI-Public: (01)00724995183660(17)20250811(11)20220812(10)2208902
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 11/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 75 KG