MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR 14 MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Catalog Number 26-1221

Device Problem Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2019

Event Type  malfunction  

Event Description

Codman disposable perforator 14 mm when used on pt did not automatically stop after going through dura.Fda safety report id# (b)(4).

• Brand Name: CODMAN DISPOSABLE PERFORATOR 14 MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. ; MA 02767
• MDR Report Key: 8816998
• MDR Text Key: 152024021
• Report Number: MW5088279
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/18/2019

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 26-1221
• Device Lot Number: J35G91
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR