MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ADVANCE - CAPSULE 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	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The advance capsule endoscope delivery devices were discarded following the reported event and are not available for evaluation.Without the return of the devices a root cause cannot be determined.The device history record (dhr) was reviewed for the subject lot and no abnormalities were noted.Steris offered in-service training to user facility personnel on the proper use and operation for the advance capsule endoscope delivery device however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure two of their advance capsule endoscope delivery devices "broke" while attempting to deliver the pill capsule.User facility personnel were able to successfully deliver the pill capsule with a third device.The patient procedure was completed successfully following a delay.No report of injury.

• Brand Name: ADVANCE - CAPSULE ENDOSCOPE DELIVERY DEVICE
• Common Device Name: CAPSULE ENDOSCOPE DELIVERY DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19042624
• Report Number: 1528319-2024-00028
• Device Sequence Number: 15264376
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: 00724995183608
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/04/2024

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: 6919768
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2023
• 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