MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE SIS EZ; POWERED LASER SURGICAL INSTRUMENT

Model Number 0644-016-01

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported that during a flexible ureteroscopy procedure for kidney stones, there was a fiber tip break.The fiber was replaced, and the procedure was completed using an alternate device.There was no patient complication.

Manufacturer Narrative

Boston scientific concludes that the reported allegations in this complaint have not been confirmed, as the product was not returned for analysis.It is likely that the procedural handling and procedural conditions of the device during set-up and use contributed to the fiber tip break.A partial break or kink could have occurred during use and when it was inserted into the scope and fired it led to the fiber break.The device instructions for use ifu states, inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.Without a returned device, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that during a flexible ureteroscopy procedure for kidney stones, there was a fiber tip break.The fiber was replaced, and the procedure was completed using an alternate device.There was no patient complication.

Manufacturer Narrative

Correction to field b1: adverse event/product problem.Correction to field b2: outcomes attrib to adv event.Correction to field b5: describe event or problem.Correction to field f10: impact codes.Correction to field h1: type of reportable event.Correction to field h6 impact codes.Boston scientific concludes that the reported allegations in this complaint have not been confirmed, as the product was not returned for analysis.It is likely that the procedural handling and procedural conditions of the device during set-up and use contributed to the fiber tip break.A partial break or kink could have occurred during use and when it was inserted into the scope and fired it led to the fiber break.The device instructions for use ifu states, inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the device; return it to the supplier for replacement.Without a returned device, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that during a flexible ureteroscopy procedure, the fiber tip broke.The fiber was replaced, and the procedure was completed using another fiber.The fiber fragments were retrieved with a zero tip basket.There were no patient complications reported.

• Brand Name: SLIMLINE SIS EZ
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18890993
• MDR Text Key: 337782836
• Report Number: 2124215-2024-14700
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 17290109147045
• UDI-Public: 17290109147045
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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: Health Professional
• Device Model Number: 0644-016-01
• Device Catalogue Number: 0644-016-01
• Device Lot Number: 0023087359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention