MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 200 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number 1912-10

Device Problem Break (1069)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that during a procedure with this fiber, a sound was heard and the fiber was found to be broken.The fiber was no longer working and it was replaced with a new one to complete the procedure without reported complications.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this fiber was thoroughly analyzed.Visual and microscopic inspection noted that there was no defect on the fiber body, as it was also received in one peace.Additionally, the tip was slightly degraded and there were burnt marks in the connector.Lastly, the fiber underwent functional testing where it was noted that the aim beam was bright and round.There is no objective evidence that the user did not properly handle or use the device according to the device instructions for use (ifu).The ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.For the moses 200 d/f/l lp fiber, verify that the ball tip is complete and not damaged.Hold the fiber tip to a non-reflective surface and ensure that a circular green spot appears.If the spot is not circular, cleave the fiber.If the spot is weak or not visible, discard the fiber or return it to the supplier for replacement.Laboratory analysis did not confirm the reported clinical observation of fiber break, therefore, an overall evaluation conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that during a procedure with this fiber, a sound was heard and the fiber was found to be broken.The fiber was not longer working and it was replaced with a new one to complete the procedure without reported complications.

• Brand Name: LUMENIS MOSES 200 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): LUMENIS LTD; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18977274
• MDR Text Key: 338763961
• Report Number: 2124215-2024-17904
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• UDI-Public: 07290109143170
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

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: 0002532307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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