MAUDE Adverse Event Report: IOGYN SYMPHION FLUID MANAEMENT ACCESSORY; IOGYN SYSTEM

Model Number FG-0203

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

During the pre-procedure prepping, the nurse noticed the fluid management accessory tray was cracked.The sterile barrier was breached so it had to be replaced with a fluid management accessory.

Manufacturer Narrative

The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant info is identified, a supplemental medwatch will be filed.

• Brand Name: SYMPHION FLUID MANAEMENT ACCESSORY
• Type of Device: IOGYN SYSTEM
• Manufacturer (Section D): IOGYN; 150 baytech dr; san jose CA
• Manufacturer Contact: matthew snodgrass ; 150 baytech dr; san jose, CA 95134 ; 4089354960
• MDR Report Key: 4736279
• MDR Text Key: 5822274
• Report Number: 3010892771-2015-00001
• Device Sequence Number: 1
• Product Code: PGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2015
• Device Model Number: FG-0203
• Device Lot Number: 36421115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1