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

Model Number SLIMLINE ENDO 200¿ FIBER

Device Problem Material Fragmentation (1261)

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

Event Date 07/27/2017

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 endo 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 endo 200 laser fiber to perform lithotripsy under flexible ureteroscope, the tip of the fiber broke off in the patient.It was further reported that at the time of the fiber break the laser part of the procedure had been considered 'finished'.The doctor safely removed the stone and fiber fragments.Patient was reported to have been fine, with no report of related injury and no report of medical intervention required to preclude permanent impairment.

Manufacturer Narrative

Product analysis 10-apr-2019.The fiber was returned for visual inspection."lot# 52760815, visual examination revealed that the fiber was broken due to excessive bending or exceeding the fiber tensile strength during use.Fiber is broken.Fiber appears pinched or twisted which would cause a break.Fiber was broken approx.10.3 feet from the rubber attached to the sma.Root cause: quality assurance: visual: handling damage - the complaint was caused by handling of the device without patient contact either during the clinical procedure or unpacking/preparation.

Manufacturer Narrative

Additional manufacturer narrative - august 1, 2018.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.The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: SLIMLINE ENDO 200¿ 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: 6950578
• MDR Text Key: 90407039
• Report Number: 3004135191-2017-00184
• 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,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2019

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: 07/28/2020
• Device Model Number: SLIMLINE ENDO 200¿ FIBER
• Device Catalogue Number: 0644-004-01
• Device Lot Number: 52760815
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/15/2017
• Supplement Dates Manufacturer Received: 07/29/2018; 04/10/2019
• Supplement Dates FDA Received: 08/01/2018; 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR