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

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).

• Brand Name: LEKSELL GAMMA KNIFE
• 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 ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 10618667
• MDR Text Key: 209557187
• Report Number: 9612186-2020-00010
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K173789
• Number of Events Reported: 1
• 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 Received: 10/02/2020
• 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 Received: 09/09/2020
• 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