MAUDE Adverse Event Report: PROMED INSTRUMENTS GMBH DORO(R) ALUMINUM SKULL CLAMP; HEADHOLDER

Model Number 3003-00

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

The customer reported on (b)(6) 2014 that there was a pt slippage and pt injury occurred.Pt was in prone position.After locking the skull clamp to 60 lbs of pressure with neck flexion, the skull clamp pins slipped.This caused a laceration over the right side of the pt's scalp.It was not a serious pt injury and the procedure was completed.

Manufacturer Narrative

Root cause: no device deviation that might have contributed to the event.Suspected root cause: wrong pinning technique.Surface finish was damaged by aggressive cleaning.Disinfection or sterilization procedure.Corrective action: instructed customer to properly position the pt's head.Ensure that the 2 skull pins in the rocker arm are equidistant from the centerline of the head and that all 3 pins are penetrating the skull equally.The angle of the pins should be as close to 90 degrees possible to the pt's skull.Test that the skull clamp ext.Arm is fully engaged in the clamp base.Lock the index knob so that the arrow and "lock" are aligned.Instructed user to lubricate metal moving parts after every wash with medical grade lubricant.Non-lubricated moving parts can dry out and can be damaged.Never steam sterilize the skull clamp, it may damage the system and shorten the life of the equipment.Returned product for use and sent user another copy of the instruction manual.

• Brand Name: DORO(R) ALUMINUM SKULL CLAMP
• Type of Device: HEADHOLDER
• Manufacturer (Section D): PROMED INSTRUMENTS GMBH; boetzinger strasse 38; freiburg 7911 1; GM 79111
• Manufacturer Contact: boetzinger strasse 38; freiburg 79111 ; 6138422242
• MDR Report Key: 4249900
• MDR Text Key: 5106740
• Report Number: 3003923584-2014-00016
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3003-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 133