MAUDE Adverse Event Report: IOGYN INC. SYMPHION RESECTING DEVICE; IOGYN SYSTEM

Model Number FG-0201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 05/13/2015

Event Type  Injury  

Event Description

During the resection procedure the machine gave "check for fluid leak" alarms.Physician felt that he may have perforated the patient's right cornua.The perforation was confirmed visually with symphion hysteroscope when advanced near the suspected perforation location.Procedure was stopped and laparoscopy was performed as a precaution.An estimated 1l of fluid was lost during this procedure.The fibroid was successfully removed and the patient was reported to be fine at the conclusion of the procedure.

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 information is identified, a supplemental medwatch will be filed.

• Brand Name: SYMPHION RESECTING DEVICE
• Type of Device: IOGYN SYSTEM
• Manufacturer (Section D): IOGYN INC.; san jose CA
• Manufacturer Contact: matthew snodgrass ; 150 baytech dr; san jose, CA 95134 ; 4089354960
• MDR Report Key: 4817774
• MDR Text Key: 19988740
• Report Number: 3010892771-2015-00002
• 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: Physician
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2016
• Device Model Number: FG-0201
• Device Lot Number: 40695481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 44 YR