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 08/21/2021

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 disengagement failure of a codman disposable perforator.The disengagement failure occurred during a craniotomy for hematoma removal procedure when making the first burr hole in the tent and dural damage was observed.Hemostasis and dural reconstruction were performed.The procedure was completed with a replacement product and the surgical time was extended more than 30 minutes.The drill used with the perforator was a midas rex (medtronic).It is unknown if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.No further information was provided by hospital.

Manufacturer Narrative

Unique device identification (udi): (b)(4) or (b)(4).The codman perforator was not returned for evaluation (as per customer, product not available); therefore, an evaluation of the device could not be performed.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: 12484807
• MDR Text Key: 271916600
• Report Number: 3014334038-2021-00191
• 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,u
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR