MAUDE Adverse Event Report: MEDIVATORS ADVANTAGE 4-CHAMBER POLYP TRAP; POLYP COLLECTION BOTTLE

Model Number	100104
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case reports that during an endoscopy procedure, the polyp trap was not capturing the biopsied polyp specimens in the chambers.The loss of specimens/polyps could potentially impact the patient in delay of patient diagnosis.There is limited information regarding this complaint.There was no reported issues with tubing connection or suction pressure being used with the device.There was no product sent back for additional analysis.There has been no reported patient illness or injury as a result.This complaint will continue to be monitored within medivators complaint system.Device not returned for evaluation.
Event or Problem Description
During an endoscopy procedure, the polyp trap was not capturing the biopsied polyp specimens in the chambers.The loss of specimens/polyps could potentially impact the patient in delay of patient diagnosis.

• Brand Name: ADVANTAGE 4-CHAMBER POLYP TRAP
• Common Device Name: POLYP COLLECTION BOTTLE
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr; conroe TX 77303
• MDR Report Key: 6055839
• Report Number: 1651395-2016-00004
• Device Sequence Number: 16162438
• Product Code: KDQ
• UDI-Device Identifier: 00677964054945
• UDI-Public: 00677964054945
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: Physician
• Device Model Number: 100104
• Device Lot Number: 807042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1