MAUDE Adverse Event Report: MECTRON S.P.A. MECTRON; MT1520+

Model Number	MT1520+
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On friday may 1st, 2026, mectron s.P.A.Was informed by the importer mectron north america of an incident, which occurred during a surgical procedure at virginia mason medical center and that might have involved one of its device.No company personnel was present at the time.The end user facility reported a case of nerve avulsion and possible durotomies during an unspecified procedure; handpiece overheating during the surgery was also reported, though it is unclear whether overheating and the surgical complications occurred at the same time.Lots, serials of the involved devices, patient information and details on the clinical sequelae of the adverse event were not reported, in spite of repeated efforts by the importer to retrieve such information.
Additional Manufacturer Narrative
Insert mt1520+ used in the surgical procedure is not available at the user's healthcare facility.The user facility has multiple handpieces available for surgeries, but is unable to report which one was used.The handpiece indicated by the importer was based purely on supposition, so it is impossible to clearly associate the correct handpiece serial number with the incident.For this reason, and due to the impossibility of retrieving additional information on the devices and the incident itself, it is not possible to conduct an investigation.

• Brand Name: MECTRON
• Common Device Name: MT1520+
• Manufacturer (Section D): MECTRON S.P.A.; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• Manufacturer (Section G): MECTRON S.P.A.; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• Manufacturer Contact: manuela galliano ; via loreto 15/a; carasco, genoa - italy 16042 ; IT 16042
• MDR Report Key: 25198978
• Report Number: 3003933619-2026-70002
• Device Sequence Number: 21359795
• Product Code: DZI
• UDI-Device Identifier: E322036000210
• UDI-Public: +E322036000210
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153743
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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 Model Number: MT1520+
• Device Catalogue Number: 03600021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown