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

Catalog Number 26-1221

Device Problems Plunge (1462); Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Date 09/10/2014

Event Type  Injury  

Event Description

Disengagement failure was noted during surgery.Perforator could not stop and caused injury to the patient's dura.It was reported that the product was not reprocessed.Bleeding was stopped and the case was completed.There was no surgical delay greater than 30 min.The patient is now followed.

Manufacturer Narrative

Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the reported problem of disengagement failure was not verified.The customer's perforator met functional test acceptance requirements.Proper engagement and disengagement was achieved with the perforator with every drilled hole.Device history records (perforator assembly) show all tests and inspections, including a drilling test, met specification requirements.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: 4101940
• MDR Text Key: 19298421
• Report Number: 1226348-2014-11989
• 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: Medical Equipment Company Technician/Representative
• 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: DG011S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2014
• 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