MAUDE Adverse Event Report: US ENDOSCOPY RAPTOR; RAPTOR GRASPING DEVICE

Model Number	00711177
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch (b)(4) that their raptor grasping device was defective/not functioning properly during a stent removal.No report of injury.
Additional Manufacturer Narrative
Steris has made multiple attempts to contact the user facility to obtain additional information regarding the reported event; however, the user facility has not responded.The device history record (dhr) was reviewed and confirmed the subject lot was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the reported event to be isolated for the subject lot.The raptor grasping device instructions for use states, "the device was designed for the removal of temporary stents.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.".A follow-up report will be submitted should additional information become available.
Additional Manufacturer Narrative
Following the submission of report 1528319-2024-00083, steris was able to obtain additional event information regarding the reported event.A steris territory manager discussed the reported event with user facility personnel who stated that the raptor grasping device subject of the reported event did not open fully during the patient procedure.User facility personnel utilized another raptor grasping device and the procedure was completed successfully.No report of injury.The raptor grasping device was not returned for evaluation.Without the return of the device a root cause cannot be determined.Steris offered in-service training on the proper use and operation for the raptor grasping device however; the user facility declined.No additional issues have been reported.

• Brand Name: RAPTOR
• Common Device Name: RAPTOR GRASPING DEVICE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20415802
• Report Number: 1528319-2024-00083
• Device Sequence Number: 8613002
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: (01)00724995183653(11)240201(17)270201(10)8357125
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: (10)8357125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown