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

Model Number	00711144
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris contacted the user facility and discussed the reported event with personnel.The user facility stated that the advance - capsule endoscope delivery device was not used on a patient and was discarded after the device would not thread properly.The device subject of the reported event is not available for return or 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 advance - capsule endoscope delivery device however, the user facility declined.The instructions for use states, "remove capsule cup from the small bag.Hold the white portion of the capsule cup between thumb and forefinger, with clear end facing out.Attach the clear end of the capsule cup onto the threaded end of the catheter by turning the capsule cup in a clockwise direction.Tighten capsule cup until it stops and the catheter begins to turn.Pull gently on the capsule cup to confirm proper connection.Hold the finger ring handle in a closed position.Push the video capsule into the capsule cup with the optical dome of the video capsule facing out.Listen for an audible click (this indicates that the capsule is appropriately seated within the capsule cup)." the device history record (dhr) was reviewed and confirmed the device was manufactured to specification; no abnormalities were noted.A complaint review was performed and confirmed this event to be isolated for the lot subject of the reported event.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our policies and procedures.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch # (b)(4) that their advance - capsule endoscope delivery device would not thread properly.No report of injury.

• Brand Name: ADVANCE
• Common Device Name: CAPSULE 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: 20156788
• Report Number: 1528319-2024-00074
• Device Sequence Number: 8301667
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 09/06/2024

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: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: (10)8344769
• 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: 08/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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