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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bradycardia (1751)
Event Type  Injury  
Manufacturer Narrative
From the literature report it can be concluded that a (b)(6) year-old patient was treated with the gamma knife (stereotactic radiosurgery) under anaesthesia. Due to improper fastening of the endotracheal tube, the tube came out of position during treatment. When trying to intubate the patient again it took 3 laryngoscopies before it was determined that the endotracheal tube had been re-positioned correctly in the oesophagus. Bradycardic cardiac arrest occurred, and the patient was taken to the intensive care unit and woke there without apparent deficits. The investigation concluded the root cause is not related to the leksell gamma knife and its accessories. Therefore leksell gamma knife did not have any malfunction and is working as designed and intended. The root cause is determined to be the lack of securing the intubation tube before the gamma knife treatment and the delayed removal of the g-frame in order to successfully re-intubate the patient.
 
Event Description
Whilst performing/completing a literature search the following case was found: christensen re, nause-]osthoff rc, waldman jc, spratt de, hearn jwd. Adverse events in radiation oncology: a case series from wake up safe, the pediatric anesthesia quality improvement initiative. Pediatr anesth. 2019;29:265-270. Https://doi. Org/10. 1111/pan. 1356. (b)(6) year-old asa 3 male for radiosurgery of brain tumor in head frame. Nurse noted pulling on circuit and tape peeling off face. Team went in after radiation powered down. Wheezing heard, albuterol given chest rise noted. Direct laryngoscopy by nurse anesthetist noted ett through cords. Endtidal carbon dioxide lost. Laryngoscopy by attending showed ett through cords but head frame hindering view. Help called, frame removed, bradycardia arrest. Epinephrine through ett and intravenous, other anesthesiologist laryngoscopy with frame off, ett in esophagus. Reintubated with rapid improvement in saturation and return of pulse. 1. 5 min chest compressions. Admitted to intensive care. Woke up hour later with no deficits. Noted that usual device to secure ett to prevent pulling was missing that day. Anesthesiologist covering one site and nurse anesthetist with additional anesthesiologist called for help. Failure to obtain or act on available information. Interpersonal conflict, crowding (lack of space).
 
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Brand NameLEKSELL GAMMA KNIFE
Type of DeviceNEUROLOGICAL 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
cornerstone
london road
crawley, west sussex RH10 -9BL
UK   RH10 9BL
MDR Report Key10618667
MDR Text Key209557187
Report Number9612186-2020-00010
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K173789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/02/2020 Patient Sequence Number: 1
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