MAUDE Adverse Event Report: LIFECORE BIOMEDICAL, LLC AMVISC PLUS; SURGICAL VISCOELASTIC MATERIAL

Model Number 60081L

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the cannula broke off during the removal of the plug.There was no pt contact.Add'l info has been requested but has not been received.

Manufacturer Narrative

Investigation of this event is on progress.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: AMVISC PLUS
• Type of Device: SURGICAL VISCOELASTIC MATERIAL
• Manufacturer (Section D): LIFECORE BIOMEDICAL, LLC; chaska MN
• Manufacturer (Section G): LIFECORE BIOMEDICAL, LLC; 3515 lyman blvd; chaska MN 55318
• Manufacturer Contact: sharon spencer, dir ; 50 technology dr; irvine, CA 92618 ; 9493985698
• MDR Report Key: 3922150
• MDR Text Key: 18002430
• Report Number: 1119279-2014-00097
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P810025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60081L
• Device Lot Number: 025097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1