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

Model Number	711099
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris account manager reported that the user facility agreed to receive additional training on the use of their etrap polyp trap.The instructions for use gives the user the following information: "inspect the package and device for shipping or handling damage, i.E.Cracked clear vessel, bent, misshapen, or missing specimen retrieval strainer(s), cracked, torn, or missing connection tube.If damage is evident: do not use these devices, save them for return, and contact your local product specialist.Caution: hang trap ensuring that the suction canister's tubing does not kink.Kinked tubing will prevent the etrap from functioning properly or may decrease or eliminate the ability to suction effectively." the device history record of the lot subject of the reported event was reviewed and no abnormalities were noted.There have been no other complaints associated with this lot.Without the return or inspection of the subject device, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported during a patient procedure that the suction cups on their etrap polyp trap did not seal properly.It has been reported the facility was able to retrieve the polyp and discarded after use.No report of injury.

• Brand Name: ETRAP - POLYP TRAP
• Common Device Name: 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: 18946841
• Report Number: 1528319-2024-00020
• Device Sequence Number: 15466669
• Product Code: KDQ
• UDI-Device Identifier: 00724995184728
• UDI-Public: 00724995184728
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 711099
• Device Catalogue Number: 711099
• Device Lot Number: 7877033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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