MAUDE Adverse Event Report: ALMA LASERS, LTD OPUS

Catalog Number	AASP12091701BA0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
On november 16th, 2023, alma lasers ltd became aware of a potential adverse event, reported by alma lasers inc., a us importer, that received a communication from a customer that reported a patient death four days post opus treatment.Alma lasers ltd, the device manufacturer, requested alma lasers inc.To retrieve the opus to alma's deport for testing, but the customer was unwilling to provide the opus system and plasma handpiece for device inspection.During the evaluation, we learned from alma customer (the initial reporter) that the cause of death most probably was a blood clot, and that the patient does have underlying medical conditions, such as high blood pressure and high cholesterol.Evaluation of the product manufacturing records (dhr) revealed that the device fully meets specification and in the approximately 16 months of use there have been no recorded instances of malfunctions or operational issues with the device.Our evaluation concluded that the death was not related to the treatment.*** uf/importer report #:3004450661-2023-00017.
Event or Problem Description
On 16-nov-2023 it was reported to alma lasers ltd about patient death that was likely caused by a blood clot.The importer had informed that the patient received an opus plasma treatment 4 day prior she passed away.
Additional Manufacturer Narrative
On november 16th, 2023, alma lasers ltd became aware of a potential adverse event, reported by alma lasers inc., a us importer, that received a communication from a customer that reported a patient death four days post opus treatment.Alma lasers ltd, the device manufacturer, requested alma lasers inc.To retrieve the opus to alma's deport for testing, but the customer was unwilling to provide the opus system and plasma handpiece for device inspection.During the evaluation, we learned from alma customer (the initial reporter) that the cause of death most probably was a blood clot, and that the patient does have underlying medical conditions, such as high blood pressure and high cholesterol.Evaluation of the product manufacturing records (dhr) revealed that the device fully meets specification and in the approximately 16 months of use there have been no recorded instances of malfunctions or operational issues with the device.Our evaluation concluded that the death was not related to the treatment.Uf/importer report #:(b)(4).Udi related data quality updates only: this supplemental report represents a correction to a previously submitted mdr the correction is performed following fda request, the udi number was added.
Event or Problem Description
On 16-nov-23 it was reported to alma lasers ltd about patient death that was likely caused by a blood clot.The importer had informed that the patient received an opus plasma treatment 4 day prior she passed away.

• Brand Name: OPUS
• Common Device Name: OPUS
• Manufacturer (Section D): ALMA LASERS, LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer (Section G): ALMA LASERS, LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer Contact: avi hirshnzon ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 18196484
• Report Number: 3004167969-2023-00014
• Device Sequence Number: 6554049
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: (01)17290110121782(11)22-07-10
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Female