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

Model Number 0644-017-01

Device Problem Break (1069)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not available for analysis to identify if there were any defects or failures with the device; therefore, the reported device performance allegation cannot be confirmed.It is likely that procedural handling and procedural conditions of the device during use contributed to the partial fiber body break.A partial body break or kink could have occurred during use, when it was inserted into the scope and fired, leading to the fiber break.The 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.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 ureteral holmium laser lithotriptation procedure, the fiber broke in the ureteroscope but did not completely break in two.The fiber was reused for 4 times before.The event occurred outside the patient.The procedure was completed with another of same device without causing harm to the patient.

• Brand Name: SLIMLINE SIS
• 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: 19020447
• MDR Text Key: 339356889
• Report Number: 2124215-2024-19232
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109145556
• UDI-Public: 07290109145556
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 04/02/2024

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: 0644-017-01
• Device Catalogue Number: 0644-017-01
• Device Lot Number: 0023083229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female