MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL VANTAGE ARC; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	1053958
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that the locking of the z-scale is broken.No patient injury has been reported.
Additional Manufacturer Narrative
H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.Locking of the z-scale has been reported by the customer to be broken and thereby insecure.The customer informed that this led to one dbs lead being replaced but no injury of the patient has been reported.The investigation determined that the root cause is wear of the aluminium locking piece in combination with the screw being replaced by the customer with a shorter screw.Wear can also be seen as a result of high torque being applied on other parts of the system i.E.Locking piece of the instrument carrier.The result is that the locking screw does not reach fully to provide secure locking.The manufacturer/supplier have analysed the screws and found that they were short but still within product specification.The locking piece should be checked each time by the customer (as stated in instructions for use) when a scale is tightened, and the parts should be inspected for wear during maintenance by the customer and any worn products should be replaced.The instructions for use clearly identify that parts shall be securely attached and properly assembled before proceeding with treatment.It can be concluded that the combination of switching to short screws, small manufactured locking margins and wear of the parts in combination has caused this problem.

• Brand Name: LEKSELL VANTAGE ARC
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• MDR Report Key: 11618771
• Report Number: 9612186-2021-00002
• Device Sequence Number: 16934158
• Product Code: HAW
• UDI-Device Identifier: 07340048304399
• UDI-Public: 07340048304399
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K190887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 1053958
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1