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

Model Number 00711652

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device subject of the reported event was requested back for evaluation.The instructions for use packet (ifu 00732074) includes the following statements, "do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met.Do not use contrast injection with this device.Use of contrast will leak out of the short wire access hole.Do not rapidly remove wires from this device.Scatter of bodily fluids and debris could occur.When using a guide wire, hold the guidewire while brushing for cellular material.Otherwise the guidewire may move and cause patient injury.This device is not to be used for any purpose other than what it is intended.Use of this device for any other purpose than what it is intended could cause patient harm (eg.Perforation, cross contamination, bleeding).Drape the catheter in a "u" shaped configuration.Remove plastic brush protector.Tighten the luer lock between the white handle and the gray y-port.Hold the proximal device end in one hand, and the distal sheath end in the opposite hand.Rinse the brush with sterile water.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.Advance the device into the accessory channel of the endoscope using short strokes (1"- 1.5") until the distal end of the sheath is endoscopically visualized.Warning: do not rapidly flush the catheter when performing salvage cytology.Scatter of bodily fluids and debris could occur.Cut the brush close to the bristles using an appropriate cutting device." the device history record for the lot number subject of the reported event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.Investigation of this event is currently in process.A follow-up mdr will be filed when additional information becomes available.

Event Description

The user facility reported that during a patient procedure the sheath wire to their infinity ercp sampling device broke while brushing the bile duct causing a procedure delay.A replacement brush was utilized in order to complete the procedure.No report of injury.

Manufacturer Narrative

The device subject of the reported event was returned for evaluation.It was found that the hypo tube attached to the handle assembly was bent.This damage is indicative of the user applying excessive force when deploying the brush or actuating the device.Additionally, it was found that the device was covered in patient biomaterial and had multiple curvatures attached to it.The attached curvatures and biomaterial can cause the brush to become stuck and overall malfunction during use.Based on the review of the returned device it was determined that the likely cause of the reported issue was user facility handling.Steris offered in-service training on the proper use and operation of the infinity ercp sampling device; however, the user facility declined.No additional issues have been reported.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Type of Device: SAMPLING 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: 17960629
• MDR Text Key: 325981595
• Report Number: 1528319-2023-00043
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 00724995184032
• UDI-Public: 00724995184032
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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 Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 4747297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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