MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 200 REUSABLE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number SLIMLINE 200 REUSABLE FIBER

Device Problem Material Fragmentation (1261)

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

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Lumenis investigated the reported event by contacting its foreign distributor to request additional information.An incident report had been provided.An investigation of the reported event found that the reported malfunction of the slimline 200 reusable fiber was similar to a device malfunction that was alleged to have caused or contributed to a potentially harmful situation.Although no injury was reported, this malfunction might lead to serious injury should it recur, and because the company is aware that a similar malfunction was alleged to have caused or continued to a serious injury (reference mdr #3004135191-2017-00002) this event represents a reportable malfunction.Should new information become available the complaint file will be reopened and updated accordingly.

Event Description

A foreign user facility reported that during a laser procedure in which a lumenis slimline 200 multiuse fiber had been utilized, the fiber had split during use at the first impact.No report of injury had been received.

• Brand Name: SLIMLINE 200 REUSABLE FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• 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: 7070003
• MDR Text Key: 94204371
• Report Number: 3004135191-2017-00221
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2017

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: Physician
• Device Model Number: SLIMLINE 200 REUSABLE FIBER
• Device Catalogue Number: 0626-221-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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