MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. QUICK CATCH IN-LINE SUCTION POLYP TRAP

Model Number 710201

Device Problem Component Missing (2306)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

User facility personnel were able to successfully retrieve the suctioned polyp.The quick catch in-line suction polyp trap subject of the reported event was not returned for evaluation.Without the return of the device a root cause cannot be determined.A complaint review confirmed this to be an isolated event for the subject lot.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure, a nurse observed that the screen was missing from the quick catch in-line suction polyp trap subsequently causing the removed polyp to become lodged in the manifold of the suction device.The patient procedure was completed successfully following a procedure delay.No report of injury.

• Brand Name: QUICK CATCH IN-LINE SUCTION POLYP TRAP
• Type of Device: QUICK CATCH IN-LINE SUCTION POLYP TRAP
• 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: 18247342
• MDR Text Key: 329493223
• Report Number: 1528319-2023-00047
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00724995184704
• UDI-Public: 00724995184704
• 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
• Report Date: 12/01/2023

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: 710201
• Device Lot Number: 7019766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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