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

Device Problems Device Issue (2379); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); No Information (3190)

Event Date 04/23/2009

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed, however the physician has informed that they believe that there was no evidence that equipment failure was involved.

Event Description

During investigation of mfr no.9612186-2017-00008 (elekta ref.#02400198), additional information of frame slippage incidents were received from the customer.The customer has reported that patient movement was observed during treatment.After treatment the pin sites showed some bleeding and the frame fixation had slight play.

Manufacturer Narrative

In the initial report both 5-day and 30-day report were ticked.Five day report was an error should be just 30-day.

Manufacturer Narrative

The investigation has been performed based upon the information given by the hospital.As the incidents occurred between 8 to 14 years ago, the information from the events are limited.There is no information on what products were used at the time of the incidents (e.G.Frame, posts or fixation screws), but according to the neurosurgeon there was no evidence that equipment failure was involved in the events.The equipment is therefore excluded to the cause of the incidents.Due to the time span of the occurrence of the events, it has not been possible to identify the root cause of the incident.A probable root cause may be that the frame was not firmly attached to the patient skull prior to treatment, and/or patient movement during gamma knife treatment.No field safety corrective action would be initiated.

• 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; flemming way; crawley, west sussex, MO RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6944013
• MDR Text Key: 89115146
• Report Number: 9612186-2017-00014
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physicist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 09/13/2017; 09/13/2017
• Supplement Dates FDA Received: 10/16/2017; 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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