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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the perforator¿s automatic disengagement mechanism did not work when the surgeon was making the 1st burr hole on (b)(6) 2017.It caused dura mater injury and brain parenchymal damage.The surgery was completed by using new perforator without any further trouble.The surgeon commented that the surgeon applied the perforator vertically to the skull when making the 1st hole.The patient¿s condition is stable now, and there is no critical damage to the patient.No further information was provided by hospital.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the visual inspection utilized the unaided eye.No anomalies were observed.Test performed , unit was found to performed as intended.Test performed, unit completed testing (5 holes) and was found to performed as intended.The dhr was reviewed by and it was verified that there were no anomalies during the manufacturing process.Complaint could not be verified.Unit was found to meet all acceptance criteria.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• 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: 6842077
• MDR Text Key: 84700474
• Report Number: 1226348-2017-10659
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• 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: H77316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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