MAUDE Adverse Event Report: RAYNHAM CODMAN 11MM DISPOSBL PERFORATR; DISPOSABLE PERFORATORS

Catalog Number 261222

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Brain Injury (2219)

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 codman disposable perforator failed to disengage during surgery and dural damage was observed.The failure occurred during the making of the first burr hole at the tent.Dural suture was performed.Another product was used for the procedure.

Event Description

N/a.

Manufacturer Narrative

Device history record (dhr)- there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis- perforator was inspected using the unaided eye.Unit was lightly soiled; no other anomalies were noted.Instruction for use (ifu) testing was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The returned unit was found to work as intended, and met all acceptance criteria.Root cause- the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.

• Brand Name: CODMAN 11MM DISPOSBL PERFORATR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11853122
• MDR Text Key: 252217243
• Report Number: 3014334038-2021-00101
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K071931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

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: 261222
• Device Lot Number: J90J70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1