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

Model Number 1912-10

Device Problems Device Damaged Prior to Use (2284); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

It was reported that during preparation, it was noticed that the fiber appeared to be cut inside of the packaging.The fiber was set aside, and the sales representative was notified.The patient was not present when the issue was observed.Analysis of the returned fiber identified a break in the fiber body.Analysis also identified the fiber had been previously used.

Manufacturer Narrative

Upon receipt of this fiber at our quality assurance laboratory, the device was thoroughly analyzed.Visual inspection of the fiber identified a break along the fiber body.The fiber was received in two pieces.Microscopic inspection identified the fiber tip was in good condition.The fiber connector was in good condition and light was passing through the face.The fiber was functionally tested by connecting it to a console.Functional testing identified a bright and disported light at the location of the break.When the fiber was connected to the console an error message was received stating the fiber expired indicating the fiber had been used.Based on analysis results, a conclusion code of unintended use error caused or contributed to event was assigned which indicates the interaction between the user and device, or sample, caused or contributed to the error.

Manufacturer Narrative

Upon receipt of this fiber at our quality assurance laboratory, the device was thoroughly analyzed.Visual inspection of the fiber identified a break along the fiber body.The fiber was received in two pieces.Microscopic inspection identified the fiber tip was in good condition.The fiber connector was in good condition and light was passing through the face.The fiber was functionally tested by connecting it to a console.Functional testing identified a bright and disported light at the location of the break.When the fiber was connected to the console an error message was received stating the fiber expired indicating the fiber had been used.Based on analysis results, a conclusion code of unintended use error caused or contributed to event was assigned which indicates the interaction between the user and device, or sample, caused or contributed to the error.

Event Description

It was reported that during preparation, it was noticed that the fiber appeared to be cut inside of the packaging.The fiber was set aside, and the sales representative was notified.The patient was not present when the issue was observed.Analysis of the returned fiber identified a break in the fiber body.Analysis also identified the fiber had been previously used.

• Brand Name: LUMENIS MOSES 200 D\F\L
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17668295
• MDR Text Key: 322478297
• Report Number: 2124215-2023-47241
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109143170
• UDI-Public: 07290109143170
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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: 0000532302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1