MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® QR3 SKULL CLAMP

Model Number 1001.001

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

The product allegedly involved in the reported incident has not yet been sent to the manufacturer for investigation.The product and additional information regarding the reported incident have been requested.As new information is received, it will be presented in a follow-up report.

Event Description

Distributor informed us on (b)(6) 2024 that one of our products was invovled in a procedure in which the treated patient sustained a laceration.

Manufacturer Narrative

As the product involved was not available for testing at the time of the initial report, the test results were supplemented in this report.Furthermore, the serial number of the product involved was corrected (d4), as the serial number of the product's torque screw (removable component) used with the skull clamp was known at the time of the initial report.Production date of the product was corrected (h4).As no deviations were found and the product sent in complies with the specification, no causal link can be established between the product in question and the incident described.Our experience is, that pinning technique can contribute to a loss of pressure and/or slippages.In this context, we refer the user to our corresponding recommendations in the instruction manual (secure the patient's head to the skull clamp): "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.".

• Brand Name: DORO® QR3 SKULL CLAMP
• Type of Device: DORO® QR3 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: nicholas preissler ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 18948311
• MDR Text Key: 338189441
• Report Number: 3003923584-2024-00006
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435506196
• UDI-Public: 04250435506196
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 1001.001
• Device Catalogue Number: 1001.001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2021
• 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 Outcome(s): Other