MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE POWERSUITE; HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASER

Model Number VERSAPULSE POWERSUITE 80/100 W

Device Problem Material Fragmentation (1261)

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

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

As part of a remedial activity, lumenis conducted a retrospective review of all its safety complaint files from january 2015 to july 2017.An investigation of the reported event found that the reported malfunction of a fiber tip breaking during a procedure was similar to a device malfunction that was alleged to have caused or contributed to a potentially harmful situation.Because the company is aware that this malfunction was alleged to have caused or continued to a serious injury (reference mdr #3004135191-2017-00002), this event represents a reportable malfunction.Subject fiber had not been returned to manufacturer for product analysis, thus root cause of the fiber break could not be determined.A lumenis technical expert examined the subject device laser system one week after the event and completed performance tests of all specifications concluding the device operated within manufacturer's specifications.The lumenis technician stated no issues were found with the laser system.In an abundance of caution lumenis is reporting this event as a product problem/malfunction.The investigation for this and similar events is being handled under (b)(4) (from complaint (b)(4)).

Event Description

A user facility reported that a laser fiber broke inside of one (1) patient during a lung treatment.No information regarding serious injury or medical intervention to preclude permanent impairment was received.

• Brand Name: VERSAPULSE POWERSUITE
• Type of Device: HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASER
• 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; 20692 ; IS 20692
• Manufacturer Contact: alan vaisman ; 6 hakidma street; po box 240; IS 20692
• MDR Report Key: 6790995
• MDR Text Key: 83249307
• Report Number: 3004135191-2017-00109
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/14/2017

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: Other
• Device Model Number: VERSAPULSE POWERSUITE 80/100 W
• Device Catalogue Number: 0638-800-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2015
• Initial Date FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1