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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Brain Injury (2219)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a perforator failed to disengage during cranial surgery for a ruptured aneurysm clipping resulting in a minor dura mater damage.The perforator failed to disengage occurred while making the three burr holes at the tentorium.Hemostasis was performed.No surgical delay was observed.The device was used with eg1(serial;unk).It is unknown if the drill was electric or pneumatic, it is unknown if the perforator clicked into place in the drill, and it is unknown if the recommended spring tests were being performed between each burr hole.The patient is in the follow-up.

Manufacturer Narrative

The perforator was not returned for evaluation (as per customer, product not available) therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer 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

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11749697
• MDR Text Key: 256753823
• Report Number: 3014334038-2021-00085
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

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
• Device Lot Number: J8736H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR