MAUDE Adverse Event Report: INTEGRA ENDOSCOPY; VENTRICULOSTOMY TUBE

Lot Number 1165009/1170088

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/09/2017

Event Type  malfunction  

Event Description

During ventriculostomy replacement, the tip of the ventric tube was found to be missing on retrieval.Upon ct scan, the 1.5 cm tip was found in the patient on imaging.

• Brand Name: ENDOSCOPY
• Type of Device: VENTRICULOSTOMY TUBE
• Manufacturer (Section D): INTEGRA
• MDR Report Key: 6721453
• MDR Text Key: 80425952
• Report Number: MW5071053
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Lot Number: 1165009/1170088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR