MAUDE Adverse Event Report: LUMENIS LTD. VERSACUT TISSUE MORCELLATOR; 2. COMMON DEVICE NAME SOFT TISSUE MORCELLATOR AND ACCESSORIES

Model Number	VERSACUT MORCELLATOR
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although no patient injury or complications related to the event were reported & no medical intervention was reportedly required to preclude serious injury, the same malfunction might result in a cancelled major procedure should it recur, thus lumenis has determined this event to be mdr reportable.Lumenis has initiated capa # (b)(4) to further investigate intermittent versacut handpiece operation, and to determine if corrective action is required.
Event or Problem Description
A foreign user facility reported that during a holep procedure in which a lumenis versacut morcellator was being utilized, "intermittent behavior of a vc handpiece occurred during a procedure.As the facility did not have a second handpiece, the procedure was completed by use of an "electro-prostatectomy".No report of patient injury was received, and the malfunction did not cause or contribute to any change in the patient's status.

• Brand Name: VERSACUT TISSUE MORCELLATOR
• Common Device Name: 2. 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: 8468016
• Report Number: 3004135191-2019-00038
• Device Sequence Number: 13831994
• Product Code: GEI
• UDI-Device Identifier: 07290109141640
• UDI-Public: 07290109141640
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: VERSACUT MORCELLATOR
• Device Catalogue Number: 0637-201-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1