MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION CODMAN®; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number 261221

Device Problem Failure to Auto Stop (2938)

Patient Problem Laceration(s) (1946)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

During surgical procedure the codman perforator did not stop when surgeon was finished drilling through the skull and tore the dura.Dura repaired and case proceeded without any additional reported event.

• Brand Name: CODMAN®
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd; mansfield MA 02048
• MDR Report Key: 12982850
• MDR Text Key: 282134379
• Report Number: 12982850
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 26-1221
• Device Lot Number: 5664421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21535 DA
• Patient Sex: Male