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

Model Number 3034-00

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

The device was inspected and tested on (b)(6) 2019.Within this inspection functional testing and visual inspection was made.Interval of the supplier maintenance was exceeded by the customer.The device was out of specification.As the device was out of specification, it generally cannot be excluded that the device has contributed to the event.From our experience 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 Description

Customer service was contacted by customer on (b)(6) 2019.Customer stated that the skull clamp was involved in a slippage.

• Brand Name: DORO® SKULL CLAMP
• Type of Device: DORO® SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 8377291
• MDR Text Key: 137363746
• Report Number: 3003923584-2019-00007
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: (01)04250435502181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3034-00
• Device Catalogue Number: 3034-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1