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

Catalog Number 261221

Device Problem Material Separation (1562)

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

Event Date 06/01/2021

Event Type  malfunction  

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 facility reported that during use, the codman disposable perforator (261221) came apart in the patient's head.No patient injury or surgical delay was reported.

Manufacturer Narrative

The perforator was returned for evaluation.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 - the perforator unit was inspected using the unaided eye.Unit was lightly soiled and was received disassembled.Ifu testing procedure was performed with no observed anomalies after being reassembled/resleeved.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.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.

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
• MDR Report Key: 12042991
• MDR Text Key: 257500727
• Report Number: 3014334038-2021-00121
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J74Y30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1