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

Model Number	00711144
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported during a patient procedure while using their advance capsule endoscope delivery device the pill cam holder became detached when delivering the pill cam and fell into the patient.The pill cam holder was retrieved and the procedure was completed successfully.No report of injury.A short procedure delay was reported.
Additional Manufacturer Narrative
Upon further investigation it was learned there were no abnormalities noted during the pre-procedure check.The advance capsule endoscope delivery device subject of the reported event was not returned for evaluation.As the device was not returned for evaluation a root cause cannot be determined.The instructions for use (ifu 731119) contains the following instructions, "if this unit does not function properly, do not use this product and please contact your local product specialist." a steris account manager offered in-service training on the proper use and operation of the advance capsule endoscope delivery device; however, the user facility has declined.The device history record (dhr) was reviewed and confirmed the lot was manufactured to specifications.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: ADVANCE
• Common Device Name: CAPSULE ENDOSCOPE DELIVERY 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: 20321152
• Report Number: 1528319-2024-00081
• Device Sequence Number: 8005354
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608(11)230524(17)260524(10)5796873
• 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): 09/27/2024

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: 05/24/2026
• Device Model Number: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: (10)5796873
• 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: 08/28/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2023
• 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