MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

Unique device identification (udi): (b)(4).The disposable perforator (id 261221) was not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

A facility reported disengagement failure of a perforator causing dural damage.A thick vein was cut through the dura mater and hemostasis was performed.The procedure was completed with a replacement product available and the event led to more than 30 minutes surgical delay.Patient recovered.The manufacturer of the drill used with the perforator was a midas, medtronic.It is unknown if the drill was electric or pneumatic, if the perforator clicked in place in the drill.It is also unknown if the recommended spring tests were performed between each burr hole.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13652640
• MDR Text Key: 286447982
• Report Number: 3014334038-2022-00042
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1