MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC. PERFORATOR; DRILLS, BURRS, TREPHINES AND ACCESSORIES (COMPOUND, POWERED)

Device Problem Device Remains Activated (1525)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

It was reported that during craniotomy procedure, single used cod man perforator did not stop and injured the dura.There was a procedure delay of 15 minutes as a result of this event and procedure was completed with backup product.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC.
• MDR Report Key: 17528396
• MDR Text Key: 321132996
• Report Number: MW5135327
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1