MAUDE Adverse Event Report: OSTA FBK DUAL INC. W/TROCAR 8/PK

Model Number 005280-901

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The cause of the reported event could not be determined.The instruction manual states, ¿upon receipt, examine the instrument and accessories for damage.Do not use a damaged product.¿.

Event Description

Olympus was informed that the sterility of the device was compromised.During preparation for use, it was found that the top of the tray was not completely sealed.A total of three devices were compromised.The devices were not used.There was no patient involvement.This is 3 of 3 reports.

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation confirmed the reported event.A visual inspection found one large area of the tyvek lid loose from the tray confirming the sterile breach.

• Brand Name: FBK DUAL INC. W/TROCAR 8/PK
• Type of Device: FBK DUAL INC. W/TROCAR 8/PK
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6197164
• MDR Text Key: 63067087
• Report Number: 2951238-2016-00966
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP870076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 005280-901
• Device Catalogue Number: 005280-901
• Device Lot Number: MK832083
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0419-2015
• Patient Sequence Number: 1