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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMPHION; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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BOSTON SCIENTIFIC CORPORATION SYMPHION; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA Back to Search Results
Model Number FG-0612-R
Device Problems Electrical /Electronic Property Problem (1198); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation revealed that corrosion was found on the motor board near the hand piece motor circuit.It appeared saline had dripped into the unit where the top cover meets the front bezel and created an electrical short on the main board.The short activated the motor circuits and thus the resecting device triggered by itself.Given the event description and condition of the returned device, the cause was traced back to component failure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion controller was used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure and outside the patient, the symphion resecting device started resecting immediately after connecting it into the symphion controller.The resecting device was inserted through the endoscope while the resecting device was activated in order to complete the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
The investigation revealed that corrosion was found on the motor board near the hand piece motor circuit.It appeared saline had dripped into the unit where the top cover meets the front bezel and created an electrical short on the main board.The short activated the motor circuits and thus the resecting device triggered by itself.Given the event description and condition of the returned device, the cause was traced back to component failure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion controller was used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure and outside the patient, the symphion resecting device started resecting immediately after connecting it into the symphion controller.The resecting device was inserted through the endoscope while the resecting device was activated in order to complete the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
 
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Brand Name
SYMPHION
Type of Device
INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7773671
MDR Text Key116863370
Report Number3005099803-2018-60021
Device Sequence Number1
Product Code PGT
UDI-Device Identifier08714729897279
UDI-Public08714729897279
Combination Product (y/n)N
PMA/PMN Number
K141848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFG-0612-R
Device Catalogue Number74076
Device Lot NumberMC-0069
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2018
Initial Date Manufacturer Received 07/20/2018
Initial Date FDA Received08/10/2018
Supplement Dates Manufacturer Received08/28/2018
Supplement Dates FDA Received09/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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