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

Catalog Number 261221

Device Problem Separation Failure (2547)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that two perforators could not be disengaged during two separate events.With the information currently available, we are not able to determine which device is associated with which event.Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.Please see medwatch 1226348-2019-00025 for information regarding the additional device.

Event Description

It was reported from (b)(6) that 2 perforators (reference 261221 / lot number j13z46) could not be disengaged.One on (b)(6) and another on (b)(6) with 2 different neurosurgeons and different motors.Device 2of 2.

Manufacturer Narrative

Udi (b)(4).The complaint sample was not returned to codman, therefore, an evaluation of the device could not be performed.Device history records (dhrs) were reviewed and no anomalies were found.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.

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: 8475640
• MDR Text Key: 140931736
• Report Number: 1226348-2019-00026
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 261221
• Device Lot Number: J13Z46
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1