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

Model Number 26-1221

Device Problem Failure to Shut Off (2939)

Patient Problem Physical Entrapment (2327)

Event Date 08/02/2017

Event Type  malfunction  

Event Description

Surgeon was utilizing midas rex drill to enter skull for craniotomy when perforator stopped and the regulator continued to spin, wrapping the cord around the device 4-5 times.Surgeon's hand was caught in the cord.

• Brand Name: CODMAN
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6893374
• MDR Text Key: 87344389
• Report Number: 6893374
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 26-1221
• Device Catalogue Number: 261221
• Device Lot Number: HA5862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MIDAS REX DRILL.
• Patient Age: 56 YR