MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® ADAPTOR; DORO® SWIVEL ADAPTOR

Model Number	3002-00
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An exact cause for the missing components cannot be determined at this time with the current state of information.The detected deviation (missing components and a corresponding loose handle) cannot remain undetected by the user during the functional and safety inspection of the product prior to use, as specified in the product's ifu.No patient was injured in this event, but due to the potential risk we decided to report this case.Further information on the problem described as well as on any safety and functional tests carried out on the product before use and the exact point in time at which the problem was discovered was requested.Any new information and/or findings, if received, will be presented in a follow-up report.
Event or Problem Description
Customer informed us on april 14 that one of our products could not be used in a procedure because a component had come loose.

• Brand Name: DORO® ADAPTOR
• Common Device Name: DORO® SWIVEL ADAPTOR
• 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: 21994594
• Report Number: 3003923584-2025-00012
• Device Sequence Number: 4478735
• Product Code: HBL
• UDI-Device Identifier: 04250435500569
• UDI-Public: 04250435500569
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/14/2025

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: 3002-00
• Device Catalogue Number: 3002-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown