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

Catalog Number 26-1221

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 12/18/2014

Event Type  Injury  

Event Description

Those perforators seem to be less performing than the previous ones.The operative time for the craniotomy is increased and there is physician discomfort.The device does not drill totally.Increase of the time of craniotomy, discomfort for the surgeon.On (b)(6) 2014 affiliate reported: were there any adverse consequences to the patient? no consequence mentioned.Was there a delay in surgery greater than 30 minutes? no information.What actions were taken as a result of this incident? no action ( but more time for craniotomy).What is the customer reference number? (b)(4).Who is the person of contact for this complaint? (b)(4).

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records have been conducted and they revealed that the device conformed to all manufacturing and quality testing/inspection specifications prior to being released to stock.If at some point the device is returned for evaluation this complaint will be re-opened and investigated.Based on this evaluation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not returned.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4398740
• MDR Text Key: 20732830
• Report Number: 1226348-2015-10015
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: KG009S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 01/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• 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