MAUDE Adverse Event Report: STERIS CORPORATION QUICKCATCH SUCTION POLYP TRAP; TRAP, STERILE SPECIMEN

Catalog Number 70201

Device Problem Component Missing (2306)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

Trap used to catch snared polyps did not have netting and did not catch resected polyp.Polyp had to be fished out of suction cannister and could have been lost without ability of pathology to examine.

• Brand Name: QUICKCATCH SUCTION POLYP TRAP
• Type of Device: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley road; mentor OH 44060
• MDR Report Key: 14572935
• MDR Text Key: 293153282
• Report Number: 14572935
• Device Sequence Number: 1
• Product Code: BYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70201
• Device Lot Number: 2203503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1