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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

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 the perforator failed to disengage during procedure for meningiomas (frontal region, and sinus straddle).The bone was stiff and a dura mater injury occurred.

Event Description

N/a.

Manufacturer Narrative

Perforator was received for evaluation: the perforator unit was inspected using the unaided eye.Eo label was gone upon arrival to investigation site.No other anomalies were noted.Failure analysis: instructions for use testing procedure was performed with no observed anomalies.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.In conclusion, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11074140
• MDR Text Key: 223717144
• Report Number: 3014334038-2020-00124
• 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
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRILLDRIVE MIDAS LEGEND