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 01/28/2021

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 facility reported that the perforator failed to disengage during surgery on a(b)(6) male patient.The perforator was used in 4 places and disengagement occurred during the first and second burr hole placements.Dural damage and a minor brain contusion were observed.Hemostasis was performed.Patient factors such as bone condition and thickness, dural adhesions, etc.Could not be assumed, and it was used so that it was perpendicular to the bone as usual.No further information was provided by hospital.

Manufacturer Narrative

Perforator was returned for evaluation: dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.The perforator unit was inspected using the unaided eye: label was illegible, lightly soiled from surgery.No other anomalies were observed.Instructions for use testing 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 the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.

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 02767
• MDR Report Key: 11357470
• MDR Text Key: 232805077
• Report Number: 3014334038-2021-00033
• 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: 05/13/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR