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

Catalog Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Device identifier # (b)(4).The perforator was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.

Event Description

A facility reported that when the surgeon was using the codman perforator on the skull bone to get access to the brain the perforator did not stop (disengage).The surgeon stopped drilling and pulled out the perforator.No patient injury and no delay in surgery was noted.

Manufacturer Narrative

Updated fields: g4,d10, g7, h2, h3, h4, h6, h10 device identifier # (b)(4).The perforator was returned for evaluation.Device history record - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - in the failure analysis that was performed, the returned 261221 perforator was found to work as intended, and met all acceptance criteria.The failure-mode could not be verified through failure analysis.The reported complaint is unconfirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

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: 10221603
• MDR Text Key: 198709378
• Report Number: 1226348-2020-00345
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 261221
• Device Lot Number: J78P67
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR