MAUDE Adverse Event Report: US ENDOSCOPY ADVANCE; ADVANCE ENDOSCOPE DELIVERY DEVICE

Model Number	00711144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported during a patient procedure that the capsule cup broke apart into the patient from their advance endoscope delivery device and had to be retrieved using a laryngoscope and magill forceps.The reported event resulted in the procedure being cancelled.
Additional Manufacturer Narrative
Steris requested the device subject of the reported event be returned for evaluation; however, user facility personnel had already discarded the device.As the device is not available for evaluation, steris is unable to determine the cause of the reported event.The device history record for the subject lot was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.The instructions for use (ifu 731119) contains the following instructions, "open and inspect the device for shipping or handling damage.If damage is evident (e.G.Bends, kinks, cracks, misshaped cup), do not use this device and contact your local product specialist.Open and close the finger rings on the handle two (2) times to make sure it moves smoothly.(moving the finger rings away from the thumb ring is open, moving the finger rings towards the thumb ring is closed).Observe that the deployment cable moves in and out.Note: the finger rings do not advance the full length of the handle shaft.If this unit does not function properly, do not use this product and please contact your local product specialist." no additional issues have been reported.

• Brand Name: ADVANCE
• Common Device Name: ADVANCE ENDOSCOPE DELIVERY DEVICE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• 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: 20020134
• Report Number: 1528319-2024-00067
• Device Sequence Number: 12930306
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: (10)7355881
• 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: 07/21/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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