MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD. NEURO OMEGA; NEURO OMEGA DRIVE HEADSTAGE

Catalog Number 750-000020-00

Device Problem Unintended System Motion (1430)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

The report is late due to technical issues we experienced with esg.

Event Description

Alpha omega`s neuro omega headstage drive was used during a routine placement of a dbs electrode neurosurgery procedure.The neurosurgeon noticed that the headstage drive was moving on its own and had moved in 2 mm.The neurosurgeon disconnected the headstage cable, restarted the system, replaced the headstage drive and cable and to continue the neurosurgery.Dbs case was completed bilaterally successfully.No adverse event was reported.

• Brand Name: NEURO OMEGA
• Type of Device: NEURO OMEGA DRIVE HEADSTAGE
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD.; hamerkava st.6; tsiporit industrial zone; nof hagalil, 17890 62; IS 1789062
• Manufacturer (Section G): ALPHA OMEGA ENGINEERING LTD.; hamerkava st.6; tsiporit industrial zone; nof hagalil, 17890 62; IS 1789062
• Manufacturer Contact: maysana mousa ; hamerkava st.6; tsiporit industrial zone; nof hagalil, 17890-62 ; IS 1789062
• MDR Report Key: 9315270
• MDR Text Key: 202515148
• Report Number: 9615126-2019-00003
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K171581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/04/2019

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 Operator: Health Professional
• Device Catalogue Number: 750-000020-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other