MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. INFINITY ERCP SAMPLING DEVICE

Model Number 00711652

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The user of the device reported unusual resistance when actuating the device during the sampling procedure.Steris endoscopy has requested further details regarding the reported event, however, the distributor has not yet been able to provide further information.Statements from the instructions for use include: "do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met.Prior to procedure, actuate the handle several times to be sure the brush functions properly.If the unit does not function properly, or there is evidence of damage (e.G., bent brush, bent brush stem, kinked catheter), do not use this product and contact your local product specialist.When using a guidewire, irrigate the guidewire lumen of the catheter with sterile water/saline." the device subject of this complaint has not been returned to steris endoscopy for evaluation.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.Steris endoscopy has requested the distributor offer in-service training on the infinity sampling device to the user facility.No further issues have been reported.A follow up report will be filed if further information becomes available.

Event Description

The distributor reported that a metal portion of the sampling device was left behind following a sampling procedure in the bile duct, as detected via cholangiogram.The user facility placed a covered stent at the site of the reported event to prevent injury to the bile duct.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Type of Device: SAMPLING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 10899970
• MDR Text Key: 221016994
• Report Number: 1528319-2020-00042
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 00724995184032
• UDI-Public: (01)00724995184032
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 2004616
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1