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

Device Problem Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Date 08/02/2017

Event Type  malfunction  

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 customer, during a craniotomy, a codman perforator, when used with a medtronic handpiece, didn't stop.It "snapped back" causing the cord of the handpiece to wrap around the surgeon's hand.Another drill and perforator were used to complete the procedure.There were no reported delays or adverse consequences.

Manufacturer Narrative

The product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.No further action is required.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.

• Brand Name: PERFORATOR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6795099
• MDR Text Key: 82713168
• Report Number: 1226348-2017-10615
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2017
• 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