MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE DISPOSABLE BIOPSY NEEDLE WITH MARKER PLATES; NEUROLOGICAL STEREOTACTIC INSTRUMENT

Model Number 41778C

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Device is manufactured exclusively for brainlab ag to be used with the stereotactic and navigation instruments.Currently the data is quite poor and investigations are ongoing.Mfr (b)(4) gmbh medizintechnologie is in contact with the initially reporting hospital as well as with distributor/ customer brainlab in order to find out more details.Trend analysis as well as batch record do not indicate any adverse result nor abnormality.This is the first reported incident of this kind with the reported device malfunction.The device urgently needs to be analyzed.As soon as more information is available an updated report will be sent in to the food and drug administration.

Event Description

Irn#: (b)(4).User facility report number: (b)(4).Describe the event or problem: or.Performed a stereotactic biopsy on this pt where he uses the disposable biopsy needle kit.Ref# (b)(4).Biopsy needle malfunctioned.The tip was not opening and closing as instructed on port.Drs did troubleshoot the issue and noted it was not functioning properly.Did not use this biopsy needle once noted.What was the original intended procedure?: stereotactic biopsy.Vlhat problem did the user have (check all that apply): device malfunction - that is, the device did not do what it was supposed to do; the device is manufactured by (b)(4) gmbh medizintechnologie exclusively for brainlab ag and distributed through brainlab in the united states of america.

Manufacturer Narrative

Device is manufactured exclusively for brainlab ag to be used with the stereotactic and navigation instruments.Currently the data is quite poor and investigations are ongoing.Mfr pajunk gmbh medizintechnologie is in contact with the initally reporting hospital as well as with distributor/ customer brainlab in order to find out more details.Trend analysis as well as batch record do not indicate any adverse result nor abnormality.This is the first reported incident of this kind with the reported device malfunction.The device urgently needs to be analyzed.As soon as more information is available an updated report will be sent in to the food and drug administration.2019-12-17 we received the following: "our clinical specialist is in contact with mrs.(b)(6), the administrative nurse at (b)(6) and they informed us that the incident occurred with dr.(b)(6) and (b)(6).The biopsy needle was cleared by (b)(6) risk management to be sent off to the manufacturer, however, by the time they received approval the device went missing.(b)(6) is currently investigating the location of the device, and will inform us once located by email.Mrs.(b)(6) is also in contact with (b)(6) (who submitted the report to fda) from (b)(6) risk management and will email us with an update once available.We are waiting on feedback regarding more complete description of this incident from dr.(b)(6) and (b)(6)." 2020-02-07 upon request we did receive the following: "based on information provided by the hospital administrative nurse ms.(b)(6), the biopsy needle was cleared by (b)(6) risk management to be sent off to the manufacturer, however, by the time they received approval the device went missing.Brainlab followed up with ms.(b)(6) but did not get any further investigation result about the location of the biopsy needle.Based also on information provided ms.(b)(6), the incident occurred with dr.(b)(6) and (b)(6).Brainlab representative met with dr.(b)(6) and (b)(6) and they both do not recall the events that occurred in (b)(6) 2019.Dr.(b)(6) expressed that they have not had any issues using the biopsy needle since.".Based on risk assessment and clinical assessment file is considered as closed.

Event Description

(b)(4).User facility report number:(b)(4).Initial reporters narrative: describe the event or problem: operating room performed a stereotactic biopsy on this pt where he uses the disposable biopsy needle kit.Ref#41778c.Biopsy needle malfunctioned.The tip was not opening and closing as instructed on port.Drs did troubleshoot the issue and noted it was not functioning properly.Did not use this biopsy needle once noted.What was the original intended procedure? : stereotactic biopsy.Vlhat problem did the user have (check all that apply) : device malfunction - that is, the device did not do what it was supposed to do.The device is manufactured by pajunk gmbh medizintechnologie exclusively for brainlab ag and distributed through brainlab in the united states of america.

• Brand Name: DISPOSABLE BIOPSY NEEDLE WITH MARKER PLATES
• Type of Device: NEUROLOGICAL STEREOTACTIC INSTRUMENT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 9325687
• MDR Text Key: 206580276
• Report Number: 9611612-2019-00036
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04048223029503
• UDI-Public: 04048223029503
• Combination Product (y/n): N
• PMA/PMN Number: K060808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2021
• Device Model Number: 41778C
• Device Catalogue Number: 41778C
• Device Lot Number: 1178
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 11 MO
• Patient Weight: 5