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 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

Lumenis investigated the reported event by contacting its foreign distributor to request additional information.Despite three (3) reasonable attempts by the foreign distributor to obtain additional information from the user facility, none had been provided other than the initial report.The initial report from the user facility claimed that the tip of the fiber broke during the procedure.The fiber was removed, the tip was renewed, and the fiber was reused once again before the tip broke a second time.The fiber had then been replaced with another of the same device, and the procedure was completed with no report of patient harm.Since lumenis cannot rule out that the fiber tip had broken off in the patient's anatomy, in an abundance of caution lumenis is reporting this event.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 serious injury (reference mdr #3004135191-2017-00002) this event represents a reportable malfunction.The device is expected to be returned to the manufacturer for product analysis.Once a cause for the reported event has been determined, lumenis will file a follow-up mdr.

Event Description

A foreign user facility reported that while a physician was using a slimline 200¿ reusable laser fiber to perform lithotripsy under flexible ureteroscope, the tip of the fiber got broken.The fiber was removed and the tip was renewed, and returned to use during the procedure.Once again the tip of the fiber got broken.The fiber was removed successfully and the case was completed with another slimline 200¿ reusable laser fiber.Patient was reported to have been fine, no report of related injury was received.

Manufacturer Narrative

One slimline 200, reusable fiber was received for evaluation on 25-aug-2017.Visual examination by a lumenis quality engineer revealed that "the tip of the fiber is broken and projecting the beam".Although the device had been received for analysis, the cause of the reported malfunction could not be determined.A lumenis quality engineer performed a review of the device history record on 11-mar-2018, concluding the product investigation.No anomalies were noted in the dhr.Since the user was reported to have noticed the malfunction and intervene before the malfunctioning device could harm the patient, and since the malfunction did not cause or contribute to any change in the patient's condition that would be considered a reportable 'serious injury', this event represents a reportable malfunction only.

• 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: 6734852
• MDR Text Key: 80813295
• Report Number: 3004135191-2017-00095
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2018

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: 01/18/2021
• Device Model Number: SLIMLINE 200 REUSABLE FIBER
• Device Catalogue Number: 0626-221-20
• Device Lot Number: 61610216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/23/2017
• Supplement Dates Manufacturer Received: 03/11/2018
• Supplement Dates FDA Received: 03/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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