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

Model Number	TRS-ROBO-12
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Bag did not retract properly.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 20842216
• Report Number: 20842216
• Device Sequence Number: 8039884
• Product Code: GCJ
• UDI-Device Identifier: 20653405986154
• UDI-Public: (01)20653405986154(17)270828(10)202408284
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/25/2024
• Report Date (Section F): 11/25/2024

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
• Operator of Device: Other
• Device Model Number: TRS-ROBO-12
• Device Catalogue Number: TRS-ROBO-12
• Device Lot Number: 202408284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 11/25/2024