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

Lot Number 170416

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

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

During acceptance inspection at an elekta warehouse foreign materials were found inside the package of disposable inserts.The disposable inserts are sterile and should not have foreign material inside the package.

Manufacturer Narrative

The investigation found that the foreign material in the pouch is plastic material, which is residue/flakes from the moulding process and probably attached to the insert inside the hole of the insert when packed prior to sterilisation.The disposable inserts are gamma radiated in 25 gy and due to the overkill sterilisation process the sterilisation process will not be affected by neither the extra insert nor the impurities.The packaging of the inserts are made in a clean area and the foreign material do not include the bioburden.This means that the sterilisation process still is effective despite the additional insert or the foreign parts in the packaging.The additional piece of insert in one of the pouches, is a human mistake when the inserts are packaged together.The root cause of the problem is the absence of inspection of the pouches content after sealing.The supplier ((b)(4)) has updated the inspection specification to include visual check of the pouch content after sealing.

• 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, RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6405315
• MDR Text Key: 70310569
• Report Number: 9612186-2017-00002
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 170416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1