MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ADVANCE - CAPSULE ENDOSCOPE DELIVERY DEVICE

Lot Number	7097793
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris requested the advance capsule endoscope delivery device subject of the reported event be sent back for evaluation.The device history record (dhr) was reviewed, and no abnormalities were noted.A complaint review determines this to be an isolated event for the subject lot.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The distributor reported that during a patient procedure their advance capsule endoscope delivery device did not deploy the capsule.User facility personnel utilized a second advance capsule endoscope delivery device and the capsule deployed.The procedure was completed successfully following a delay.No report of injury.
Additional Manufacturer Narrative
Steris made multiple attempts to obtain additional information regarding the reported event and to obtain the advance capsule endoscope delivery device back for evaluation however, the complainant has not responded.A follow-up report 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: 19534329
• Report Number: 1528319-2024-00047
• Device Sequence Number: 8251485
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: 00724995183608
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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 Lot Number: 7097793
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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