MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Failure to Auto Stop (2938)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

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 perforator during surgery.It occurred during the first burr hole, the physician made a total of three burr holes.It is unknown if there was patient injury or surgical delay.

Manufacturer Narrative

The perforator (261221) was returned for evaluation: failure analysis - the perforator unit was inspected using the unaided eye.Unit was lightly soiled from surgery and had partially worn label that could not be read.No other anomalies were observed.Ifu testing was performed per procedure with no observed anomalies.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.The returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.Root cause - product was received for analysis and the investigation could not confirm the complaint.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A trending and risk assessment were performed as part of the evaluation.The risk remains acceptable per the risk analysis.

• 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: 11600168
• MDR Text Key: 256758024
• Report Number: 3014334038-2021-00062
• 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: 06/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1