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

Model Number 3034-00

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

It could not be clarified whether an injury to the patient had occurred, but as there was a potential risk reported ("head slipped") we decided to report this case.As the device was out of specification due to wear and tear, it generally cannot be excluded that the device has contributed to the event.The interval of the supplier maintenance was exceeded for more than 10 years by the customer.Due to this circumstance, we cannot exclude that the deviations found are the result of normal wear and tear and could have been detected during annual maintenance.

Event Description

Customer informed our service department on the 30th of april that the patients head slipped during a procedure.

• 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
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: christopher schmitz ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 11900738
• MDR Text Key: 253475308
• Report Number: 3003923584-2021-00013
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435502181
• UDI-Public: 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2021

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: 3034-00
• Device Catalogue Number: 3034-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other