MAUDE Adverse Event Report: CONMED CORPORATION ANCHOR TISSUE RETRIEVAL SYSTEM; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number TRS175SB2

Device Problems Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 03/19/2019

Event Type  malfunction  

Event Description

Surgeon was doing a robotic lobectomy and a conmed anchor tissue retrieval system was inserted to remove the lobe and a tear was noted on the rim of the bag.The bag was removed and not used.A 2nd bag was opened, and it would not close properly.This bag was also removed and not used.A 3rd bag was inserted and though it was not used, when it was removed, it worked without issues.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 8514371
• MDR Text Key: 141953615
• Report Number: 8514371
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TRS175SB2
• Device Catalogue Number: TRS175SB2
• Device Lot Number: 201808215, 201808075, 16A8T
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1