MAUDE Adverse Event Report: LSI SOLUTIONS, INC FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES; CULDOSCOPE AND ACCESSORIES

Model Number 110035

Device Problems Fire (1245); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

Lsi received medwatch form # mw5075034 from cdrh on (b)(6) 2018.On (b)(6) 2018, lsi reached out to cdrh via email in an attempt to obtain information regarding the user facilty contact information associated with the event.Cdrh infomred lsi that the original report contained all of the releasable information available and that they would not be providing any additional information.Without any additional information regarding the user facitliy or obtaining the device in question, lsi is unable to investigate this event any further.The event will be captured in the lsi complaint system as complaint number (b)(4), for trending purposes.No other actions will be taken in regard to this event.If additional information is received or if the device is returned, lsi will reopen and further investigate the event.

Event Description

Light cord became dislodged from fornisee device, which resulted in a burned drape.This event meets the joint commission of an operating room fire, and could have resulted in a permanent injury or death.

• Brand Name: FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
• Type of Device: CULDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): LSI SOLUTIONS, INC; 7796 victor mendon road; victor NY 14564
• Manufacturer (Section G): LSI SOLUTIONS, INC.; 7796 victor-mendon road; victor NY 14564
• Manufacturer Contact: melissa conley ; 7796 victor mendon road; victor, NY 14564 ; 5857845859
• MDR Report Key: 7343479
• MDR Text Key: 102742874
• Report Number: 1320468-2018-00001
• Device Sequence Number: 0
• Product Code: HEW
• PMA/PMN Number: K111014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Model Number: 110035
• Device Lot Number: 692269
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other