MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. SUCTION POLYP TRAP

Model Number	710202
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel who were present at the time of the reported event stated that a filter was missing from one of the suction polyp containers which subsequently allowed the polyp to go into the waste section of the device instead of the suction container.As user facility personnel could not locate the suctioned polyp, the patient procedure was cancelled.The instructions for use provides the following information to the user: "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage (i.E.Deformed, cracked vessel, missing component, or damaged packaging), do not use this product and contact your local product specialist." the suction polyp trap device was returned to steris for evaluation, and it was confirmed that the filter was missing.A complaint review has confirmed this to be an isolated event for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, personnel were utilizing a suction polyp trap and observed the specimen to be "lost" in the suction container.The patient procedure was cancelled.No report of injury.

• Brand Name: SUCTION POLYP TRAP
• Common Device Name: 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: 17966655
• Report Number: 1528319-2023-00044
• Device Sequence Number: 6790328
• Product Code: KDQ
• UDI-Device Identifier: 00724995183479
• UDI-Public: 00724995183479
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: 710202
• Device Catalogue Number: 710202
• Device Lot Number: 5835816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown