MAUDE Adverse Event Report: LUMENIS LTD. SLIMLINE 550¿ REUSABLE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number SLIMLINE 550¿ REUSABLE FIBER

Device Problem Material Fragmentation (1261)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation of the reported event found that the reported malfunction of the slimline 200 fiber 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 potentially harmful situation (reference mdr #3004135191-2017-00002) this event represents a reportable malfunction.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

A foreign user facility reported that while a physician was using a slimline 550 laser fiber during the laser enucleation part of a holep procedure, the tip of the fiber broke off in the patient.The tip was retrieved as waste fluid, and the procedure was completed with another slimline 550 fiber.There were no patient complications reported as a result of this event.

Manufacturer Narrative

One slimline 550¿ reusable fiber was received for evaluation on (b)(6) 2018.Visual examination revealed that the fiber was broken, not melted.Fiber appeared pinched or twisted which would cause a break.Fiber was broken approx.9.2 feet from the rubber attached to the sma.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.A review of the device history record was performed, no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.Therefore, a review and analysis of all information indicated that the most probable root cause is operational context, the fiber was most probably broken due to excessive bending or exceeding the fiber tensile strength during use.

• Brand Name: SLIMLINE 550¿ REUSABLE FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 7171060
• MDR Text Key: 97640436
• Report Number: 3004135191-2018-00010
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K140388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

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 Expiration Date: 09/28/2020
• Device Model Number: SLIMLINE 550¿ REUSABLE FIBER
• Device Catalogue Number: 0624-149-55
• Device Lot Number: 55051015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1