MAUDE Adverse Event Report: LSI SOLUTIONS FORNISEE FS-30

Device Problems Melted (1385); Overheating of Device (1437); Material Separation (1562); Smoking (1585)

Patient Problem No Information (3190)

Event Date 10/28/2015

Event Type  malfunction  

Event Description

The above patient, (b)(6), had a laparoscopic hysterectomy on (b)(6) 2015.During the surgery, smoke was noted from the forinsee fs-30 light source.The device was immediately removed from the patient care area and kept for additional investigation.The investigation is below: on (b)(6) 2015 clinical engineering services (ces) obtained the light cable and fornisee fs-30 disposable instrument used during the case.The light source was not quarantined during this incident due to lsi solutions previous findings which indicated blood/fluid intrusion at the light cable port to be the root cause of the problem.These findings led ces to investigate the fs-30 disposable hand piece in an effort to try and recreate the incident results.Upon review of the fs-30 disposable instrument it was found that the threaded plastic light port on the rear of the instrument was melted with most of the light port embedded in the light cord.These findings were consistent with those seen during the investigative process following the first incident on (b)(6) 2015.Ces obtained a new fs-30 hand piece from surgery for simulated testing.It was noted that the instrument had a thin gap between the two plastic halves near the light port which could allow for fluid intrusion to occur between the light cord and the light pipe inside the instrument.These findings were also consistent with observations made during the first investigation.The new fs-30 handpiece was connected to a light source (quarantined in ces from the (b)(6) 2015 incident) via a 5mm light cord.The handpiece was positioned at an angle believed to be similar to that of the original procedure while the cervical cup was placed inside a foam padded container in an effort to mimic the surgical site.A small amount of blood was then placed in the instrument channel and around the light cord connection port of the handpiece.The light source was turned on and its output was set to max intensity.After 45 minutes, it was observed that the light connection port on the fs-30 had overheated and started to separate from the rest of the main body of the handpiece.Two minutes later, the port had completely separated.The investigative process suggested that blood intrusion occurred within the light cord connector port and blocked the natural light path through the handpiece.This allowed heat to build up within the connector port which eventually transferred to the surrounding plastic, causing it to melt.Note: while additional simulations were performed (with and without blood), ces was unable to recreate the findings from the first attempt.On (b)(6) 2015, ces contacted the manufacturer of the handpiece (lsi solutions) and notified them of the incident.They requested that the handpiece and light cord be sent in for an internal review by their engineers and emailed instructions for return.All pertinent devices were photographed before being sent to lsi solutions under (b)(4).Ces is currently awaiting the final report from lsi solutions investigation.

• Brand Name: FORNISEE FS-30
• Type of Device: FORNISEE FS-30
• Manufacturer (Section D): LSI SOLUTIONS; victor NY 14564
• MDR Report Key: 5412408
• MDR Text Key: 37622728
• Report Number: MW5060023
• Device Sequence Number: 1
• Product Code: HEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 142