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

Catalog Number 26-1221

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Scarring (2061)

Event Date 04/08/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the craniotomy procedure using xmax, csr60 and the perforator in question was performed for the patient with meningioma ((b)(6)-year-old female,).After perforation, white burn-like scars were found on the brain surface just under each of all 6 burr holes.According to the surgeon, the patient¿s skull was thick and hard (over 1 cm), and it took about 2 or 3 minutes to perforate each burr hole.Also, csr60 was found heated after the perforation though irrigation had been conducted during the procedure.The perforator had not been reprocessed.There was no problem with the disengagement mechanism and no dura injury was caused.The patient has no sign of any impairment after surgery.

Manufacturer Narrative

(b)(4).It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

• 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: 4765736
• MDR Text Key: 5949084
• Report Number: 1226348-2015-10281
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2015
• 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
• Patient Age: 39 YR