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

Model Number 00711653

Device Problem Activation Problem (4042)

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

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

Upon follow-up with the user facility, steris endoscopy learned that the reported event occurred prior to the procedure leading to a brief delay in beginning the patient procedure; however, the planned procedure was completed successfully.The user facility representative stated that the device subject of this complaint is not available for return to steris endoscopy for evaluation.The lot number of the device subject of this event is unknown.Statements in the instructions for use regarding testing prior to procedure include: drape the catheter in a "u" shaped configuration.Rinse the brush with sterile water.Actuate the handle several times to be sure the brush functions properly." steris endoscopy has offered in-service training on the use of the infinity ercp sampling device to the user facility; however, the facility has declined.No further issues have been reported.

Event Description

The user facility reported via user facility medwatch report 2600320000-2020-8250 that the infinity ercp sampling device would not deploy.There was no reported of harm to the patient or user of the device.

• 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: 11210606
• MDR Text Key: 229297570
• Report Number: 1528319-2021-00003
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2021

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: 00711653
• Device Catalogue Number: 00711653
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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