MAUDE Adverse Event Report: LUMENIS LTD VERSAPULSE POWERSUITE; POWERED LASER SURGICAL INSTRUMENT

Model Number GA-0006600

Device Problem Output below Specifications (3004)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that during preparation, when laser firing was tried to perform, an error message on red screen was displayed.Due to this, the procedure was not completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under sedation.

Manufacturer Narrative

D3/g1 additional email: (b)(6).

• Brand Name: VERSAPULSE POWERSUITE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; 1-1 ebisu-cho, kanagawa-ku; yokohama-shi, kanagawa, 14 221-0 024; JA 221-0024
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18437781
• MDR Text Key: 331985804
• Report Number: 2124215-2023-74715
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109146171
• UDI-Public: 07290109146171
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA-0006600
• Device Catalogue Number: GA-0006600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1