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U.S. Department of Health and Human Services

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

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IOGYN INC. SYMPHION RESECTING DEVICE; IOGYN SYSTEM Back to Search Results
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.
 
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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 Key4817774
MDR Text Key19988740
Report Number3010892771-2015-00002
Device Sequence Number1
Product Code PGT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141848
Number of Events Reported1
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 Date02/27/2016
Device Model NumberFG-0201
Device Lot Number40695481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2015
Initial Date FDA Received06/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age44 YR
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