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

Catalog Number 261221

Device Problem Activation Problem (4042)

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

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Device identifier # (b)(4).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 the surgeon complained that the codman disposable perforator did not stop and plunged through the dura while doing a burrhole for drainage of a chronic subdural.The surgeon had to pull out the perforator.There was no direct injury to the brain.No surgical delay was noted.

Event Description

N/a.

Manufacturer Narrative

Device identifier # (b)(4).The perforator was returned for evaluation: device history record (dhr): there is no indication that the production process may have contributed to this complaint.Failure analysis: visually inspected utilizing unaided eye: organic matter and a wrong eto label was found.The complaint could not be verified through failure analysis.Tested with in the specifications (ifu testing, functional testing).The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• 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: 10221598
• MDR Text Key: 200774749
• Report Number: 1226348-2020-00354
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J57D54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1