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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP
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PRO MED INSTRUMENTS GMBH DORO® SKULL CLAMP Back to Search Results
Model Number 3003-00
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device did not show any deviation that could cause the reported incident.We suspect, that maybe the pinning technique has been not optimal as described in the instruction manual: "adjust the skull clamp to the width of the patient's head in the manner that the two skull pins in the rocker arm are equidistant from the centerline of the head and the single skull pin at the extension assembly is in line with this centerline.".
 
Event or Problem Description
Customer service was contacted on (b)(6) 2019 by customer.Customer stated, that there was slippage with a patient.
 
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Brand Name
DORO® SKULL CLAMP
Common Device Name
DORO® SKULL CLAMP
Manufacturer (Section D)
PRO MED INSTRUMENTS GMBH
boetzinger str. 38
freiburg, 79111
GM  79111
MDR Report Key9537432
Report Number3003923584-2019-00028
Device Sequence Number2245468
Product Code HBL
UDI-Device Identifier04250435500743
UDI-Public(01)04250435500743
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K001808
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/10/2019
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? No
Operator of Device Health Professional
Device Model Number3003-00
Device Catalogue Number3003-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/10/2019
Initial Report FDA Received Date01/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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