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

Device Problems Failure To Adhere Or Bond (1031); Device Issue (2379); Device Operational Issue (2914)

Patient Problems Abrasion (1689); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported a stereotactic procedure had to be paused, and subsequently discontinued when the frame moved on one of the posts.The patient received an injury to the brow caused by a fixation pin tip, when the frame moved.It is unclear at this time how the frame moved, therefore an investigation is ongoing.

Manufacturer Narrative

The manufactures investigation found that a patient got a wound when the frame slipped during lgk perfexion treatment.At the time of the incident the treatment was immediately aborted.The actual injury was a cut over the eyebrow.The root cause has not been identified but the probable cause of the event is insufficient tightening of a fixation post to the frame g prior to gamma knife perfexion treatment.No malfunction parts or damage to the frame system were identified.There is no evidence that equipment failure was involved in the event.Firm fixation of the frame is essential to be able to perform a gamma knife treatment and there are instructions and warnings included in the instructions for use to ensure a stable fixation.

• Brand Name: LEKSELL STEREOTACTIC SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; kungstensgatan 18; 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: 6766825
• MDR Text Key: 81819127
• Report Number: 9612186-2017-00006
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 152558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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