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

Model Number TRS100SB2

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2018

Event Type  malfunction  

Event Description

Reusable tissue retrieval bag became dislodged from device in patient.All pieces retrieved.No patient harm.Device removed from service and replaced.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7600479
• MDR Text Key: 111043453
• Report Number: 7600479
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/12/2018

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: Physician
• Device Model Number: TRS100SB2
• Device Catalogue Number: TRS100SB2
• Device Lot Number: 01A8T
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR