MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD SHIELDED ALPHAPROBE MICROELECTRODE

Model Number	STR-AP9080-00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The facility reporter described the event as follows: "describe the event or problem: supply was tested by surgeon before using it on patient and supply was found to be "manufactured incorrectly." what was the original intended procedure? craniotomy, deep brain stimulator with microelectrode recording, first array.What problem did the user have: device malfunction - that is, the device did not do what it was supposed to do.
Additional Manufacturer Narrative
This event was not reported to alpha omega engineering ltd.In real time.Our application specialist, alpha omega rep., was in touch with the facility.The neuroprobe alphaprobe was not send for manufacturer evaluation, we assume it was a mechanical issue, we asked the probe for further evaluation.The facility used alternative probe during the procedure.

• Brand Name: SHIELDED ALPHAPROBE MICROELECTRODE
• Common Device Name: SHIELDED ALPHAPROBE MICROELECTRODE
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD; hamerkava st. 6 pob 810; tsiporit industrial zone; nof hagalil, northern israel 17890 62; IS 1789062
• Manufacturer (Section G): ALPHA OMEGA ENGINEERING LTD; hamerkava st. 6 pob 810; tsiporit industrial zone; nof hagalil, noethern israel 17890 62; IS 1789062
• Manufacturer Contact: efrat shamgar ; hamerkava st. 6 pob 810; tsiporit industrial zone; nof hagalil, northern israel 17890-62 ; IS 1789062
• MDR Report Key: 20703590
• Report Number: 3001610756-2024-00002
• Device Sequence Number: 9812091
• Product Code: GZL
• UDI-Device Identifier: 07290014954946
• UDI-Public: 07290014954946
• Combination Product (Y/N): N
• PMA/510(K) Number: K120098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

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
• Device Expiration Date: 07/16/2026
• Device Model Number: STR-AP9080-00
• Device Catalogue Number: STR-AP9080-00
• Device Lot Number: 87976
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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
• Patient Sex: Unknown