MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 550 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number 1912-10

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that during holmium laser enucleation of the prostate (holep), it was noticed that the fiber was broken.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that during holmium laser enucleation of the prostate (holep), it was noticed that the fiber was broken in the box before use.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that during holmium laser enucleation of the prostate (holep), it was noticed that the fiber was broken in the box before use.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Boston scientific concludes that the reported allegations in this complaint have not been confirmed, as the product was not returned for analysis.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 not established was assigned to this investigation.This event was originally coded for a fiber break.However, review of the reported information indicates that the fiber was found to be broken before use.There was no reported permanent impairment or damage to the patient and no medical or surgical intervention was required.There was no information to reasonably suggest that the event could potentially cause or contribute to a death or serious injury if the event were to reoccur.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

• Brand Name: LUMENIS MOSES 550 D\F\L
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6,; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; hakidma st 6; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19008499
• MDR Text Key: 339102411
• Report Number: 2124215-2024-18608
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: 07290109143453
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0003892312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2023
• 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