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

Model Number 0644-020-01

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that during a holmium laser enucleation of the prostate (holep) procedure, the physician over-rotated the scope during a difficult case, resulting in a fiber break and a minor skin injury.The information about the patient and procedure outcome are unknown.

Event Description

It was reported that during a holmium laser enucleation of the prostate (holep) procedure, the physician over-rotated the scope during a difficult case, resulting in a fiber break and a minor skin injury.The information about the patient and procedure outcome are unknown.

Manufacturer Narrative

Correction to field b1 and h1.

Manufacturer Narrative

With all the available information, boston scientific concludes that the reported event could not be confirmed.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.In regards of the minor skin injury, it is considered as a known inherent risk of device use as stated in the instructions for use.Based on review of all information available and analysis results, the investigation did not identify any abnormality in manufacturing or design from the risk review, conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that during a holmium laser enucleation of the prostate (holep) procedure, the physician over-rotated the scope during a difficult case, resulting in a fiber break and a minor skin injury.The information about the patient and procedure outcome are unknown.

• 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): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19090303
• MDR Text Key: 339981338
• Report Number: 2124215-2024-21888
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 17290109145669
• UDI-Public: 17290109145669
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0644-020-01
• Device Catalogue Number: 0644-020-01
• Device Lot Number: 0009201222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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): Other