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

Model Number	VERSACUT TISSUE MORCELLATOR
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Perforation (2001); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis contacted its foreign distributor to obtain further information about the reported allegations; despite reasonable attempts, no additional information had been provided.A review of the subject device dhr confirmed that the subject device was manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.Manufacture date: 29-jun-2017 and installed at the customer's facility on 06-sep-2017.A review of subject device risk files ((b)(4)) revealed the risk of "non-excised/unintended tissue engaged by morcellator" resulting in a 'perforation of bladder wall' as a known risk.The risk carries a hazard severity of 6 (serious injury requiring non surgical medical treatment).The risk has been characterized and documented as acceptable within full risk assessment.Despite reasonable attempts lumenis has been unable to obtain additional information regarding the circumstances surrounding the alleged 'bladder perforation'.While the information received to date does not confirm that a serious injury occurred; because of the lack of information the company is reporting the event in an abundance of caution.Should additional relevant details become available; a supplemental report will be submitted.
Event or Problem Description
A foreign distributor reported that one of its customers alleged performance issues during use of their lumenis versacut morcellator system.The customer alleged issues with "suction not (being) trustable" during the morcellation part of holep procedures and as a result there have been "some accidents with bladder injuries".The customer further alleged that "when the problem occurs during procedures they change the tubing and blades.Sometimes they cannot do the morcellation procedure at all and the patient has to come back for another operation in the following days, or they tried to minimize the tissue with bipolar resection.".
Additional Manufacturer Narrative
Additional information 30-may-2019.On (b)(6)-2019 lumenis received an incident form filled out by a urologist at the complainant facility.The complainant alleged morcellator issues of "poor aspiration, insufficient or no morcellation after aspiration, and very prolonged morcellation time.", further noting "i can't make it to 10-12 (ten to twelve) grams per minute of morcellation.We changed the blade sets very often, but found no difference".The urologist indicated that "another handpiece and blade set is sometimes necessary to finish the procedures in time, we always have 1-2 'spare' handpieces and blade sets.", and "morcellation time was very very prolonged, and some days we had to cancel the last patient of our operating room that day, and had to operate him a week later." nowhere in the incident form is reference to any patient injury or complications; specifically 'bladder perforation'.On (b)(6) 2019 the distributor, and lumenis certified service provider, indicated that "the morcellator system (control box) was checked and it's working fine." equipment from the reporting facility was returned to the manufacturer for evaluation.Equipment was received 21-may-2019 and evaluated by r&d.[*]handpiece (s0024) was tested by connecting it to a similar versacut control box in the r&d lab.Upon initial activation of the handpiece no anomalies were observed.Upon pressing the foot pedal the hp, motor motion felt [?]normal'.[*]the blades set from andros was then observed.The blades were assembled on the handpiece, locked into position, and the device was activated in a tub of water.No malfunction was observed.[*]a piece of chicken breast was added into the tub of water and the handpiece was activated again to simulate morcellation.The system performed per specifications.No problem was observed neither with the morcellation nor the suction.R&d conclusion : returned device review (visual, physical, and/or performance testing) showed no evidence of either the alleged issue(s) or any defect which could have contributed to the alleged event.The facility has requested that the equipment be returned following the manufacturer's evaluation.The equipment has been returned and to the best of lumenis' knowledge remains in use at the facility.Corrected data lumenis has changed b1 of this report to product problem only, and h1 is being changed to malfunction only.Additionally, the patient code in h6 has been changed from perforation to no known consequences to patient.

• 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: 8567802
• Report Number: 3004135191-2019-00052
• Device Sequence Number: 13837176
• Product Code: GEI
• UDI-Device Identifier: 07290109140681
• UDI-Public: 07290109140681
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K050639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VERSACUT TISSUE MORCELLATOR
• Device Catalogue Number: 0637-245-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/30/2019
• 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: Other