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

Model Number 3020-50

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

The customer has not yet sent in the product for investigation.The customer was fairly confident that this was user error due to the surgeon being unfamiliar with 4 pin fixation, so the device will not be to send in for inspection.We will perform a follow-up if the product arrives.

Event Description

Customer informed us on the 14th of september that one of our products was involved in a procedure (4 pin configuration) in which a laceration occured to the patient.

• Brand Name: DORO® MULTI PURPOSE SKULL CLAMP
• Type of Device: DORO® MULTI PURPOSE SKULL CLAMP
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 17918594
• MDR Text Key: 325444163
• Report Number: 3003923579-2023-00026
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435501689
• UDI-Public: 04250435501689
• 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
• Type of Report: Initial
• Report Date: 09/14/2023

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: 3020-50
• Device Catalogue Number: 3020-50
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/14/2023
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other