MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTACTIC INSTRUMENT, PRODUCT CODE: HAW

Model Number 11868

Device Problems Degraded (1153); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/05/2016

Event Type  No Answer Provided  

Event Description

During investigation of another event, some issues were found with the accuracy of the closed ct indicator box.The closed ct indicator box was attached to an empty g-frame with posts and imaged in ct.Comparison made with the same frame but with the open ct indicator box attached, shows accuracy problems with the closed ct indicator box.The device is being returned to the manufacturer facility for investigation.

Manufacturer Narrative

Eventually the item was returned to the manufacturer.The device is concluded to be at least 25 years old (manufactured 1990 or earlier) this explains accuracy problems.The user manual contains clear warnings that a product in this condition should not be used.The device greatly exceeds the guaranteed support of five years indicated in the user manual.Defects were found indicating extensive use and exposed to some rough handling and repairs, and was missing some parts.Joints repaired using glue that is not the correct specification and the copper fiducials were very corroded and in some places had come loose.

• Brand Name: LEKSELL STEREOTACTIC SYSTEM
• Type of Device: NEUROLOGICAL STEREOTACTIC INSTRUMENT, PRODUCT CODE: HAW
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer Contact: pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5619563
• MDR Text Key: 44717889
• Report Number: 9612186-2016-00005
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K152558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other