MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. SUCTION POLYP TRAP; CONTAINER, SPECIMEN STERILE

Model Number 710202

Device Problem Misassembled (1398)

Patient Problem No Information (3190)

Event Date 06/06/2018

Event Type  malfunction  

Event Description

Pre-assembled suction polyp trap.Suction tubing assembly attached to scope tubing in error resulting in polyp being suctioned into suction canister lost.

• Brand Name: SUCTION POLYP TRAP
• Type of Device: CONTAINER, SPECIMEN STERILE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC. ; mentor OH
• MDR Report Key: 7600558
• MDR Text Key: 111159864
• Report Number: MW5077839
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710202
• Device Catalogue Number: 710202
• Device Lot Number: IAP57-1804
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 76