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

Catalog Number 1006559

Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

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 found that one of the feet pins under the left plate of the open mr indicator box is loose on the 3rd day of the start-up week on the (b)(6).This open mr indicator box is quite new and was used only once for treatment the (b)(6).The problem was found when the customer was making ready for the second usage on the (b)(6).

Manufacturer Narrative

The serial number refers to the mr indicator box, which is part of the leksell stereotactic system (stereotaxic instrument).

Manufacturer Narrative

The manufacturer's investigation concluded that the steering pins of the open mr indicator box had come loose.It was found that the gluing process of the steering pins was insufficient.In order to make the steering pins stay permanently to the open mr indicator box a design change will be considered.

• 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: 5868201
• MDR Text Key: 51867090
• Report Number: 9612186-2016-00006
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1006559
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• 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