MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERFORATOR DISSECTING TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Patient Problem Brain Injury (2219)

Event Type  Injury  

Event Description

It was reported that during deep brain stimulation procedure the perforator didn't stop.It was also reported that there was no intervention due to the procedure.Additional information regarding the patient impact was being followed up from the facility.On follow-up it was reported that, the injury appears to have been caused with the reusable other manufacturer perforator (manufactured by bbraun).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERFORATOR DISSECTING TOOL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 17799911
• MDR Text Key: 324166433
• Report Number: MW5146049
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/15/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2023
• Patient Sequence Number: 1