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

Model Number	0638-808-01
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the versapulse did not start during a procedure.The error 221 was showed in the screen.The patient was under general anesthesia and the procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
D3/g1: additional manufacturer email: (b)(4).Upon the field service performed for boston technical services, it was noticed that the screw of the main safety shutter came off.It is likely that the loose screw from main safety shooter resulted in the issuance of error 221 (service attenuator test failed).Therefore, the reported allegation is confirmed.The screw was tightened, and it was confirmed that the console was working as expected.Based on the information received, a conclusion code of cause traced to maintenance was assigned to this complaint.
Event or Problem Description
It was reported that the versapulse did not start during a procedure.Error 221 was displayed on the screen.No patient complications were reported.This complaint is being reported for a cancelled procedure with a patient under general anesthesia.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16479782
• Report Number: 2124215-2023-08641
• Device Sequence Number: 19620709
• Product Code: GEX
• UDI-Device Identifier: 07290109140599
• UDI-Public: 07290109140599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0638-808-01
• Device Catalogue Number: 0638-808-01
• Device Lot Number: 004-63518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown