MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	912877
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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.This mdr concerns disposable inserts and fixation screws which is used with the leksell stereotactic frame.The disposable inserts themselves are labelled single use.However, the fixation screws and the leksell stereotactic system are not labelled single use.
Event or Problem Description
The customer reported that the fixation screws does not feel rigid when mounted in the disposable inserts.
Additional Manufacturer Narrative
Section d4 lot # added.Section d9 updated.Section h3 updated.Section h6 coding added.Section h10 additional information.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The user reported that the play in their latest batch of disposable inserts is larger than before and was concerned if the fixation was as rigid as previous batches.Elekta performed a comparison set of tests with the complaint batch (#0190868) received from the customer and three previous batches of disposable inserts.The investigation concluded that the larger play seen does not affect the rigidity of the fixation and thereby the safety when using the disposable inserts used by the customer (batch #0190868).This is likely to be due to the thread of the batch of inserts used by the customer which is slightly larger than the previous batches due to production variables which is within specification.The rigid fixation is addressed in the instructions for use.The user is instructed to check the firm attachment of the frame before starting the treatment (tug test).There was no patient injury.

• Brand Name: LEKSELL STEREOTACTIC SYSTEM
• 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: 11601233
• Report Number: 9612186-2021-00001
• Device Sequence Number: 2988219
• Product Code: HAW
• UDI-Device Identifier: 07340048304474
• UDI-Public: 07340048304474
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K151159
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: Health Professional
• Device Model Number: 912877
• Device Lot Number: 0190868
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1