MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP

Model Number	3003-00
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the device was out of specification due to wear and tear, it generally cannot be excluded that the device has contributed to the event.The interval of the supplier maintenance was exceeded for more than 8 years by the customer.Due to this circumstance, we cannot exclude that the deviations found are the result of normal wear and tear and could have been detected during annual maintenance.
Event or Problem Description
Distributor informed our service department on the 12th of july that he wants to send in one of our products for repair.Attached was information about an incident.Further information about this incident was received on the 8th of november.Patient suffered a laceration.

• Brand Name: DORO® SKULL CLAMP
• Common Device Name: DORO® SKULL CLAMP
• 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: christopher schmitz ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 15860389
• Report Number: 3003923584-2022-00018
• Device Sequence Number: 6901505
• Product Code: HBL
• UDI-Device Identifier: 04250435500743
• UDI-Public: 04250435500743
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 07/12/2022

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 Model Number: 3003-00
• Device Catalogue Number: 3003-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2013
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown