MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® ADJUSTABLE BASE UNIT; DORO® ADJUSTABLE BASE UNIT,

Model Number	3001-00
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor informed us on may 23 that one of our products was involved in a procedure whose completion had to be cancelled and rescheduled due to misalignment of the system.Specifically, the product was reportedly used for the first time in a procedure on april 20.During the procedure, the responsible surgeon noticed that the clamping unit (movable housing with clamping function on the support tube of the base unit) of the product was incorrectly positioned, which led to a shift in the position of the patient's skull and which is why the treating surgeon decided to postpone the completion of the procedure to another date.The reporter describes that after careful inspection of the product, the team concluded that there was an inadvertent displacement of the product's tension adjustment device, thus reducing the tension setting, which allowed the clamping unit (which is connected to the skull clamp fixing the patient's head) of the device to shift.In a second subsequent feedback, the user describes a further use of the product carried out on may 18 without incidents or other anomalies, during which the integrity and optimal functioning of the product is confirmed, the procedure is satisfactorily completed and a report on the optimal functioning of the doro device is prepared.According to the reporter, the process of implementing the cranial support accessory has been satisfactorily completed and the correct functioning, adjustment and positioning on the operating table has been demonstrated.
Additional Manufacturer Narrative
Based on customer feedback, it is currently assumed and according to the current state of information that the displacement of the clamping housing on the base unit was possible due to insufficient tension.The user is informed of the correct adjustment and verification of this as part of the product's instructions for use.The product and additional information on the incident were requested and will be presented in a follow-up report if applicable.

• Brand Name: DORO® ADJUSTABLE BASE UNIT
• Common Device Name: DORO® ADJUSTABLE BASE UNIT,
• 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: 19575170
• Report Number: 3003923584-2024-00018
• Device Sequence Number: 17158122
• Product Code: HBL
• UDI-Device Identifier: 04250435500019
• UDI-Public: 04250435500019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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 Model Number: 3001-00
• Device Catalogue Number: 3001-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown