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 04/17/2024

Event Type  malfunction  

Manufacturer Narrative

D3/g1 additional email: moshe.Barenboym@bsci.Com.

Event Description

It was reported that during a ureterorenoscopy procedure, it was noticed the fiber used broke in half.Due to this, the procedure was completed using another fiber.There were no patient complications.

Event Description

It was reported that during a ureterorenoscopy procedure, it was noticed the fiber used broke in half in the case.Due to this, the procedure was completed using another fiber.There were no patient complications.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.

• 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: 19159937
• MDR Text Key: 341404941
• Report Number: 2124215-2024-23755
• 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: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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: 0003532311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2023
• 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