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	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that two advance capsule endoscope delivery devices broke during a procedure.The procedure was completed successfully and there was report of procedure delay.No report of injury.
Additional Manufacturer Narrative
The customer reported the cap came off the first delivery device when ejecting the capsule.The customer then utilized a second delivery device where the handle broke when ejecting the capsule.The customer was able to troubleshoot issues and successfully complete the procedure by taking the capsule cup from the second delivery device and attach it to the first delivery device.The two delivery devices were returned and reviewed by a quality systems specialist.While reviewing the first delivery device it was determined the device was damaged prior to the incident and that damage likely attributed to the error.While reviewing the second delivery device it was learned that the handle broke apart due to the inner drive cable becoming free from the hypo tube during ejection.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." following the reported event, user facility personnel declined in-service training and stated they would contact steris should additional in-service training be needed.The device history record (dhr) was reviewed and confirmed the lot was manufactured to specifications.The complaint log was reviewed for similar events, and this is the only reported event regarding this issue.A follow-up mdr will be submitted should additional information become available.No additional issues have been reported.

• 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: 19051126
• Report Number: 1528319-2024-00029
• Device Sequence Number: 15292313
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: 00724995183608
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/05/2024

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: 7355881
• 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: 03/07/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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