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

Model Number 1912-10

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that during a procedure the fiber was broken.The procedure was completed using another fiber.There were no patient complications.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this fiber underwent a thorough analysis.The fiber was received in one piece and no fiber breaks were identified.Therefore, the reported event was not confirmed.Microscopic inspection confirmed the tip was in good condition; in addition, burn marks were found in the fiber connector face.The fiber was functionally tested, and the aim beam was bright and round.The console read error 67.Fiber expired.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

Event Description

It was reported that during a procedure the fiber was broken.The procedure was completed using another fiber.There were no patient 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): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18826801
• MDR Text Key: 336908238
• Report Number: 2124215-2024-12645
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• UDI-Public: 07290109143170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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: 0002262307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• 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