MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1221

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Sales rep reported that the product will not be returned.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At the present time this complaint is considered closed.Device not available.

Event Description

Unknown neurosurgery resident used the anspach eg1 drill with perforator attachment and disposable codman perforator to create craniotomy.When drill stopped, resident mentioned they could see the underlying dura was compromised.They decided to try another access point on the cranium and again commented the underlying dura at this site was also compromised.It is not immediately known if the drill or disposable cutter malfunctioned and created the dural injury, if the resident made an error or if the patient had dural adhesions.The same drill, perforator attachment and disposable perforator was used throughout the surgery.Patient was described as female and elderly.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6443448
• MDR Text Key: 71168194
• Report Number: 1226348-2017-10204
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention