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

Model Number	00711144
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility has not responded to multiple attempts to obtain additional information.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.The device subject of this complaint has not been returned to steris endoscopy for evaluation.Statements from the instructions for use include: "the disposable advance capsule endoscope delivery device is a 2.5mm single sheathed device indicated for transendoscopic delivery of capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm - 26.5mm in length), to the stomach or duodenum.Attach the clear end of the capsule cup onto the threaded end of the catheter by turning the capsule cup in a clockwise direction (see fig 3).Tighten capsule cup until it stops and the catheter begins to turn.Pull gently on the capsule cup to confirm proper connection." steris endoscopy has requested that the distributor offer in-service training to the user facility.A follow-up report will be filed if additional information becomes available.
Event or Problem Description
The distributor reported that the capsule holder component of the advance capsule endoscope delivery device became detached during deployment of the video capsule.The capsule holder remained attached to the capsule endoscope, causing the video capsule lens to be shaded during the procedure.The distributor stated the event made the procedure more difficult for the physician and stated the event was associated with patient harm.No intervention was reported.

• Brand Name: ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE
• Common Device Name: DELIVERY DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 10692735
• Report Number: 1528319-2020-00037
• Device Sequence Number: 3185322
• Product Code: NEZ
• UDI-Device Identifier: 00816765011188
• UDI-Public: (01)00816765011188
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K163495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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 Expiration Date: 12/20/2021
• Device Model Number: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: 1820692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1