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 Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported the perforator failed to disengage during placement of the first burr hole for a craniotomy.The dura mater was injured.The device was used as is to complete the procedure.There was no further information provided.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi)- (b)(4).Device history record (dhr)- no review performed given the lot number is unknown.Failure analysis- device was visually inspected - device was received disassembled and exhibited damage on the outside body of the outer drill.Ifu and functional tests: unit was found to perform as intended.Therefore,complaint could not be verified.Perforator was found to meet all acceptance criteria / tested within the specifications.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: 10280989
• MDR Text Key: 202689543
• Report Number: 1226348-2020-00405
• 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: 06/25/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1