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

Model Number VERSACUT+ TISSUE MORCELLATOR

Device Problems Partial Blockage (1065); Battery Problem (2885)

Patient Problems Urinary Tract Infection (2120); Hemolytic Anemia (2279)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

A foreign hospital reported that during a holep procedure a physician experienced a functional issue with operational performance of a lumenis versacut+ tissue morcellator.The physician reported a difficulty of morcellation resulting in extended surgical procedure while a patient was under anesthesia.The physician described a lack of effective morcellation of the adenoma tissue resulting from tissue blockage in the blades.The physician stated a need to release the adenoma tissue and resume morcellation from a different angle, resulting in a patient sustaining a serious bladder injury complicated with a pelvic venous wound requiring emergency laparotomy and four units of blood transfusion.The patient was subsequently admitted to the icu, per physician report.

Manufacturer Narrative

Lumenis investigated the event report contacting its foreign distributor to obtain further information regarding the event.Additionally, lumenis requested that the hospital return the unit to the manufacturing site for performance evaluation.The subject lumenis versacut+ morcellator device was decontaminated and returned, as requested.No further patient information was provided to the distributor by the hospital, in accord with local laws.Lumenis technical design and quality engineers examined the subject device handpiece, concluding the handpiece piston and seal were found to be out-of-specification resulting in water leak secondary to seal-wear.The water leak resulted in an electrical short and functional inconsistencies of the cutting blades.The out-of-specification piston and seal were determined to be the root-cause of the customer's complaint.

• Brand Name: VERSACUT+ TISSUE MORCELLATOR
• Type of Device: SOFT TISSUE MORCELLATOR AND ACCESSORIES
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma street po box 240; yokneam industrial park; yokneam, israel 2069 2; IS 20692
• Manufacturer (Section G): LUMENIS, LTD.; 6 hakidma street po box 240; yokneam industrial park; yokneam, israel 2069 2; IS 20692
• Manufacturer Contact: steve kachocki ; 1870 milestone drive; salt lake city, UT 84104 ; 8775863647
• MDR Report Key: 4721228
• MDR Text Key: 16853335
• Report Number: 3004135191-2015-00026
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: VERSACUT+ TISSUE MORCELLATOR
• Device Catalogue Number: GA-0007600
• Other Device ID Number: 1402-001-00016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• 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
• Patient Outcome(s): Other