MAUDE Adverse Event Report: US ENDOSCOPY TALON; GRASPING DEVICE

Model Number	00711175
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported their talon grasping devices did not perform as intended during a patient procedure.Another talon grasping device was utilized to successfully complete the procedure resulting in a short delay.No report of injury.
Additional Manufacturer Narrative
One device was returned and reviewed by a quality systems specialist.Upon review, it was confirmed the catheter was buckled below the handle assembly.The clinical manager identified there was no issue found with the returned device and the most likely cause was excessive force when actuating the device to grasp a foreign body.The instructions for use states, "only use this device with diagnostic and therapeutic scopes.Do not use if the device is damaged or if the sterile barrier has been compromised.Save the device and packaging and contact your local steris endoscopy product specialist.The following conditions may cause the device to function improperly: (1) attempting to pass or open the device in an extremely articulated endoscope, (2) attempting to actuate the device in an extremely coiled position, and/or (3) actuating the device when the handle is at an acute angle in relation to the sheath.Drape the device in a "u" shaped configuration, holding the proximal device end in one hand, and the distal sheath end in the opposite hand.With the device in this position, carefully retract the handle until the grasping claws are completely retracted into the sheath.Check that the accessory channel diameter of the endoscope is compatible (2.8mm or larger) with the diameter of the talon® grasping device (2.5mm sheath)." the device history record of the lots subject of the event were reviewed and confirmed the lots were manufactured to specification; no abnormalities were noted.No other complaints were identified related to these related lots.Steris offered in-service training on the proper use and operation of the devices; however, the user facility has not yet responded.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
In-service was offered on the proper use and operation of the talon grasping device, however the user facility declined.No additional issues have been reported.

• Brand Name: TALON
• Common Device Name: 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: 20678239
• Report Number: 1528319-2024-00101
• Device Sequence Number: 7229704
• Product Code: FGO
• UDI-Device Identifier: 00724995182786
• UDI-Public: (01)00724995182786(11)230810(17)260810(10)6353964
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/13/2024

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 Expiration Date: 08/10/2026
• Device Model Number: 00711175
• Device Catalogue Number: 00711175
• Device Lot Number: (10)6353964, (10)8850070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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