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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the perforator was used during craniotomy of the right frontal and temporal bone.However, the auto release did not work during the first perforation and the dural injury and hemorrhage occurred.Hemostasis was achieved by gauzes and surgicels.Therefore another perforator with different lot number was used from the second perforation.And there were no anomalies confirmed.The patient is recovering well and the procedure completed successfully.The perforator was not re-sterilized and was used as per the ifu.The concomitant drill was a midas legend by medtronic.The perforated bone was normal.The location of the targeted site was the right frontal and temporal bone.The perforator was used perpendicular to the bone during use.No further information was provided by the hospital.The product will be returned to your site.

• Brand Name: CODMAN DISP PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8364057
• MDR Text Key: 136979696
• Report Number: 1226348-2019-10123
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: J11X95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Other