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

Model Number VERSACUT MORCELLATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Although no report of injury was received, and the device malfunction did not cause or contribute to any change in the patient's condition, lumenis is aware that the same malfunction was alleged to have caused or continued to an 'adverse event' (cancelled procedure of an anesthesized patient : mdr# 3004135191-2017-00186).Lumenis is reporting this event as it represents a reportable malfunction.Lumenis initiated (b)(4) to continue its investigation of this and similar reported events, and to determine corrective action.

Event Description

A foreign user facility reported that during a holep procedure in which a lumenis versacut tissue morcellator was being utilized, "the handpiece didn't work so smoothly".A second handpiece was used to complete the procedure.No report of injury was received, and no report that the device malfunction caused or contributed to any change in the patient's condition.

• Brand Name: VERSACUT TISSUE MORCELLATOR
• Type of Device: SOFT TISSUE MORCELLATOR
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 7564053
• MDR Text Key: 109898304
• Report Number: 3004135191-2018-00085
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 06/03/2018

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
• Device Operator: Physician
• Device Model Number: VERSACUT MORCELLATOR
• Device Catalogue Number: 0637-201-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/03/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1