MAUDE Adverse Event Report: BLACK FOREST MEDICAL GMBH DORO LUCENT® SKULL CLAMP (1101.001)

Model Number	1101.001
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of writing, the device in question had not yet been received for examination, therefore no conclusive assessment of the incident described can be provided at this time.The reporting party has been requested to provide the product and additional information regarding the reported incident.Any relevant findings will be included in a follow-up report, when applicable.
Event or Problem Description
Customer (distributor) informed us that one of our products was involved in a case in which a laceration occurred.

• Brand Name: DORO LUCENT® SKULL CLAMP (1101.001)
• Common Device Name: DORO LUCENT® SKULL CLAMP
• Manufacturer (Section D): BLACK FOREST MEDICAL GMBH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): BLACK FOREST MEDICAL GMBH; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger strasse 86; freiburg im breisgau, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 24378535
• Report Number: 3003923584-2026-00005
• Device Sequence Number: 20049227
• Product Code: HBL
• UDI-Device Identifier: 04250435532355
• UDI-Public: 04250435532355
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K240319
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 1101.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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