MAUDE Adverse Event Report: CODMAN PERFORATOR; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown part number, udi unavailable.Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the ous affilate, a perforator failed to disengage, tearing the patient's dura and became stuck in the skull.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the unit was visually inspected utilizing unaided eye.It was noted that both the blue sleeve and the outer drill had been damaged during use.Test performed, unit was found to performed as intended.As received, the unit completed testing (5 holes) and was found to performed as intended.Due to the damaged condition in which the unit was received in, the unit was then broken down and reassembled with a new blue sleeve.Once reassembled, the unit completed tm084 testing (5 holes) and was also found to performed as intended.The dhr (pn: 261221_bn: ha3888_) was reviewed 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 PERFORATOR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6897789
• MDR Text Key: 87521391
• Report Number: 1226348-2017-10701
• Device Sequence Number: 1
• Product Code: JXG
• 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: 09/27/2017
• 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: HA3888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2018
• 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