MAUDE Adverse Event Report: CONMED ANCHOR TISSUE RETRIEVAL SYSTEM

Lot Number 39C6T

Device Problem Defective Component (2292)

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

Event Date 08/21/2017

Event Type  malfunction  

Event Description

Anchor tissue retrieval system's draw string did not close and had to manually put specimen in bag to retrieve.Diagnosis or reason for use: cholelithiasis.

• Brand Name: ANCHOR TISSUE RETRIEVAL SYSTEM
• Type of Device: ANCHOR TISSUE RETRIEVAL SYSTEM
• Manufacturer (Section D): CONMED
• MDR Report Key: 6812633
• MDR Text Key: 83516664
• Report Number: MW5071740
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Lot Number: 39C6T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 74