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

Lot Number 2022040

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Retrieval bag arms failed when surgeon tried to removed bag.Bag was then cut off in order to get the arms out of the trocar.Rep has been contacted.Retrieval bag has been placed in red bag and sent to risk management.

• Brand Name: ANCHOR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 16903373
• MDR Text Key: 315032221
• Report Number: MW5117426
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2022040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Sex: Female