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

Model Number 3034-00

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

No patient was injured in this case, but due to the potential risk we decided to report this case.We suspect that misuse of the device caused the incident.

Event Description

Customer service was contacted on (b)(6) 2020 by the customer.Customer stated that a part of the skull clamp broke down during patient positioning.Customer stated a potential risk.No patient injury.

• Brand Name: DORO® SKULL CLAMP RADIOLUCENT
• Type of Device: DORO® SKULL CLAMP RADIOLUCENT
• 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: erasmus baumann ; boetzinger str. 38; freiburg, 79111 ; GM 79111
• MDR Report Key: 9870902
• MDR Text Key: 191818084
• Report Number: 3003923584-2020-00006
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/03/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1