MAUDE Adverse Event Report: LUMENIS LTD. VERSACUT TISSUE MORCELLATOR; SOFT TISSUE MORCELLATOR AND ACCESSORIES

Model Number	VERSACUT MORCELLATOR
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis regional offices contacted the user facility directly to investigate the reported event.Patient information, treatment settings, and the facility's report of the event were requested from the user facility and provided.A review of the subject device history record (dhr) determined that the subject device was manufactured and tested according to manufacture specifications.The device was manufactured on 18-feb-2016 and was installed at the user facility on 30-may-2016.A review of subject device user manual (0631-060-01_g) revealed the following messages and warnings concerning flow direction.Test the system before patient operation: using aseptic technique, submerge the tip of the assembled blade set in sterile saline solution.Fully press the footswitch to ensure that the blades reciprocate; the handpiece motor starts smoothly and liquid flows through the system.Also ensure that the liquid is flowing in the direction of the arrow on the label adhered to the pump head, and on top of the system's casing.Warning: aspiration flows in the direction of the arrow on the pump head.Always verify that the aspiration tube is loaded in the required direction.There is no aspiration: probable cause: the aspiration tubing is installed in the reverse position in the aspiration pump head.Suggestion: insert the aspiration tubing into the pump head as instructed in the operation section of this manual.Furthermore, there is a label on the control unit's front panel which illustrates the aspiration flow direction from the handpiece to the tissue collection container a 'safety committee' was assembled on 18-jan-2019 in order to conduct a 'survey and verification' of the incident.Results of that committee concluded that "it was evident that the user had incorrectly set & prepared the morcellator suction tubes which caused the inability to remove the tissue during the procedure.Although it is considered a necessity to inspect the device prior to beginning the procedure, it apparently was not done.The facility upon realizing during the procedure that the tubing was incorrectly set, immediately reset the tubing correctly and the device performed with proper suction until the procedure was successfully completed.System malfunction is not suspected as being the cause of the event; the user's reverse setting of the suction was found to be the only relationship between the patient's health damage and the equipment." a review and analysis of all available information concluded that device operator failure to follow subject device ifu & common medical practice to be the determined probable cause of the event reported.
Event or Problem Description
A foreign user facility reported that on (b)(6) 2019 during a holep procedure in which a lumenis versacut morcellator was being utilized to remove prostate tissue from a patient, the doctor noticed that the patient's vital signs reached a critical level.It had been observed that the versacut handpiece was not 'aspirating effectively'.Upon checking the system, it was found that the handpiece was improperly prepared; the suction tubing had inadvertently been set-up in the opposite direction causing the flow to be reversed.The tubing was reset in the correct manner and the procedure was successfully completed.Although the vital signs of the patient showed signs of improvement after the morcellation was completed, the patient remained unconscious and was moved to the icu where he remained unconscious for five days.It was later reported on 30-jan-2019 by the facility's 'hospital officer' that although the patient had regained consciousness, the patient was showing difficulty in 'moving his body and communication'.The officer further noted that these prognostic symptoms might remain due to hypoxia.To the best of lumenis' knowledge, the patient still remains hospitalized at the date of this report.

• Brand Name: VERSACUT TISSUE MORCELLATOR
• Common Device Name: SOFT TISSUE MORCELLATOR AND ACCESSORIES
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8303779
• Report Number: 3004135191-2019-00013
• Device Sequence Number: 1634680
• Product Code: GEI
• UDI-Device Identifier: 07290109140681
• UDI-Public: 07290109140681
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VERSACUT MORCELLATOR
• Device Catalogue Number: 0637-245-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Disability
• Patient Age: 85 YR
• Patient Weight: 47