MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® EASY-CONNECT NAVIGATION ADAPTOR; DORO® EASY-CONNECT NAVIGATION ADAPTOR, BRAINLAB

Model Number	1204.002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are currently no known patient incidents involving due to the error described in this report.However, as there is a risk based on the information available, we have decided to report this issue and initiate a recall, to establish full compatibility of the devices by revising the interface and to minimize a possible patient risk as far as possible.
Event or Problem Description
During a comparison of the drawings of the products 1204.002 doro® easy-connect navigation adapter, brainlab and 41725 standard cranial reference array, it was determined that in certain instances the compatibility of both devices might be compromised.This might have an influence on the positioning of the reference array.Due to that an influence of the function of the navigation system cannot be excluded.

• Brand Name: DORO® EASY-CONNECT NAVIGATION ADAPTOR
• Common Device Name: DORO® EASY-CONNECT NAVIGATION ADAPTOR, BRAINLAB
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 21607462
• Report Number: 3003923584-2025-00009
• Device Sequence Number: 18508385
• Product Code: HBL
• UDI-Device Identifier: 04250435506738
• UDI-Public: 04250435506738
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1204.002
• Device Catalogue Number: 1204.002
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown