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

Model Number 1001.001

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The user did not remove the pins as described in the instruction for use, this contributed to the described event: "to remove a used skull pin from the skull clamp, replace the protective sleeve over the pin point.Grasp the colored polymer base or o-ring base and rotate clockwise while pulling to remove.In order to prevent injuries caused by the pin points remove the extension assembly from the skull clamp by pulling the release knob.".

Event Description

Customer gave our sales the information, that there has happened an incident: we've been reported an incident when a nurse got injured, when trying to remove the pins from the skull clamp.

• Brand Name: DORO® SKULL CLAMP
• Type of Device: DORO® SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 8844514
• MDR Text Key: 152750432
• Report Number: 3003923584-2019-00021
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Date Manufacturer Received: 07/01/2019
• 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