MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE DISPOSABLE BIOPSY NEEDLE DBN

Model Number	41779C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported by worldwide exclusive distribution partner brainlab.Based on the information available, the risk assessment as well as clinical assessment this file is considered as closed.
Event or Problem Description
(b)(4).Tentative translation from initial reporters narrative: the surgeon reported that there were severe complications after biopsy operation.Afterwards the patient had a neurological deficit and was 13 days in-house (instead 1-2 days normally).Negative effect explanation: massive bleeding.

• Brand Name: DISPOSABLE BIOPSY NEEDLE DBN
• Common Device Name: DISPOSABLE BIOPSY NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 13802692
• Report Number: 9611612-2022-00004
• Device Sequence Number: 3966872
• Product Code: HAW
• UDI-Device Identifier: 04048223029503
• UDI-Public: 04048223029503
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2026
• Device Model Number: 41779C
• Device Catalogue Number: 41779C
• Device Lot Number: 1407 OR 1409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown