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

Model Number	1053958
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigations have ascertained that both of the screws for the stop and guide holder knobs were screwed out of position and protruded in a way that they tilted the instrument carrier.This tilt caused a larger shift in the target.This protrusion is prevented by design by both gluing of the threads as well as a press fit pin that will ensure the unscrewing to never occur.The pins could not be found in any of the two screws on this specific instrument carrier.There was no sign that the pins had been forced out of position.The root cause has been found to be two missing press fit pins, that have been omitted by the manufacturer on this unit.No adverse effect of the patients have been reported.The same design and manufacturer (third party supplier) have been used for a long time and this has never been seen in the past (one-off occurrence).To make sure that the pins were in place for other instrument carriers, 17 instrument carriers were investigated.All had both pins in place.The manufacturer (third party supplier) will implement a final check that the pins are positioned correctly.
Event or Problem Description
The customer reported that the instrument carrier locking pins were missing.

• Brand Name: LEKSELL VANTAGE ARC 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: 9920330
• Report Number: 9612186-2020-00005
• Device Sequence Number: 3257831
• Product Code: HAW
• UDI-Device Identifier: 07340048304399
• UDI-Public: 07340048304399
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: 1053958
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1