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

Model Number 3034-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  Injury  

Event Description

Distributor informed our sales department on the 15th of february that one of our products was involved in a case where the customer was unable to remove the skull clamp from the patient's head.

Manufacturer Narrative

This pressure spring deviation may have been detected during the annual maintenance, but the product has not been sent in for the maintenance for the last 3 years.However, this deviation cannot contribute to the reported event.We were not able to reproduce the failure reported and could not identify the root cause of the event.

• Brand Name: DORO ® SKULL CLAMP RADIOLUCENT
• Type of Device: DORO ® SKULL CLAMP RADIOLUCENT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 16500953
• MDR Text Key: 310853101
• Report Number: 3003923579-2023-00006
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 04250435502181
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3034-00
• Device Catalogue Number: 3034-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other