MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG PROVIDO; SURGICAL MICROSCOPE

Model Number	10448704
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Event or Problem Description
Leica microsystems (schweiz) ag received a complaint from spain stating that a provido had a loss of function during a surgical procedure.There was no patient injury.
Additional Manufacturer Narrative
This is a final report.An investigation was conducted on the returned power supply.The returned part was connected to the power supply tester for failure verification.When switched on, all 4 ports (1 x 12v & 3 x 24v) had no leds lit up and the internal cooling fan was not running.There was no 12v and 24v power output when measured using a multimeter.The power supply was found to be faulty.An examination by the supplier revealed a crack line on component (b)(4).The cause can be traced to a weakness in the manufacturing process controls.Corrective actions have already been implemented at the supplier, the assembly process and the layout of the power supply was enhanced.These activities are covered under capa-lis-md-22-001-re (improvement project).The defective power supply was replaced by a new one.

• Brand Name: PROVIDO
• Common Device Name: SURGICAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• Manufacturer (Section G): LEICA INSTRUMENTS (SINGAPORE) PTE LTD; 12 teban gardens crescent; singapore, 60892 4; SN 608924
• Manufacturer Contact: manuel pfundstein ; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• MDR Report Key: 21178139
• Report Number: 3003974370-2025-00002
• Device Sequence Number: 4262712
• Product Code: EPT
• UDI-Device Identifier: 07630003577112
• UDI-Public: (01)07630003577112(11)231006
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 10448704
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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
• Patient Sex: Unknown