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 06/16/2020

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 dura mater injury due to disengagement failure of the perforator during the 3rd burr-hole at temporal bone (it was found that no bone pad was made at the 3rd burr-hole).Hemostasis to the injury was performed and the procedure was completed with a replacement product.The first and second burr-holes were made without any problem.

Manufacturer Narrative

Updated fields: d10, g4, g7, h2, h3, h6, h10 device identifier: (b)(4).The perforator was returned for evaluation: device history record (dhr) - the dhr could not be reviewed as the batch number was unknown.Failure analysis - complaint could not be verified.Unit was found to perform as intended.Unit was found to meet all acceptance criteria.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: 10249658
• MDR Text Key: 198096028
• Report Number: 1226348-2020-00372
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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: 07/30/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELAN DRILL DRIVE.; ELAN DRILL DRIVE