MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE BRAINPRO BIOPSIEKANÜLEN SET; BRAINPRO CLASS III BIOPSY CANNULAE SET, PRODUCT CODE:HAW

Model Number 41779C

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still running.As soon as further information becomes available a follow up report will be sent in to the agency.The claimed brainpro biopsy needle from the set art.No.41779c that we have delivered to brainlab is for the brainlab complete system for brain biopsies in which our product is integrated and used by brainlab.We supply a class iii product to this system.The product code is therefore selected as haw and entered as such under part d / d2b.

Event Description

Irn# (b)(4).Biopsy needle not recognized by cranial 3.X software (instrument options) during case: during technical investigation brainlab determined the following contributing root cause factor (one out of three factors which led to the deviating biopsy path): image data show that the trajectory is at the edge of the burr hole/near bone, which could have led to bending of the brainlab-distributed biopsy needle when making contact with the bone during insertion and have led to a deviation of the needle tip.Further, the needle was used for this procedure without a stopper, which is not recommended.Thus, the actual depth of the needle could not be tracked by the user, which allowed for a trajectory beyond the expected target.

• Brand Name: BRAINPRO BIOPSIEKANÜLEN SET
• Type of Device: BRAINPRO CLASS III BIOPSY CANNULAE SET, PRODUCT CODE:HAW
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str.7; geisingen
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str. 7; geisingen 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen 78187 ; 0499291586
• MDR Report Key: 18787136
• MDR Text Key: 337525933
• Report Number: 9611612-2024-00003
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 41779C
• Device Catalogue Number: 41779C
• Device Lot Number: 1491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention