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

Model Number TRS100SB2

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

During the surgery when surgeon try to pull out the purple pouch tissue retrieval system tear in to 2 pieces.The pouch's pieces are found and complete.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13602
• MDR Report Key: 16337491
• MDR Text Key: 309306536
• Report Number: MW5114810
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2023

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
• Device Operator: Health Professional
• Device Model Number: TRS100SB2
• Device Catalogue Number: TRS100SB2
• Device Lot Number: 202209135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White