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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA Back to Search Results
Model Number FG-0202
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2016
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was under the age of 18.Reported event of pressure sensor failed.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a symphion fluid management accessories device was used during a uterine hysteroscopic myomectomy procedure performed on (b)(6) 2016.According to the complainant, during hysteroscopy, the controller alarmed and presented a "pressure sensor failure" error message.The fluid management accessories kit was replaced with another of the same, and the procedure was successfully completed.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.
 
Manufacturer Narrative
(b)(4).Investigation results: one symphion fluid management accessory was returned for analysis.A visual evaluation of the returned device noted that the pressure sensor relief valve was detached.A functional evaluation noted that it was possible to insert the pressure sensor connector into the receptacle on the controller, and it was possible to physically connect the pressure sensor to the endoscope.The pressure sensor was detected by the console; however, it was not possible to set the cavity pressure on the console due to the detached pressure sensor relief valve.Device analysis determined that the condition of the returned device was consistent with the reported event.The investigation concluded that the noted failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a symphion fluid management accessories device was used during a uterine hysteroscopic myomectomy procedure performed on (b)(6) 2016.According to the complainant, during hysteroscopy, the controller alarmed and presented a "pressure sensor failure" error message.The fluid management accessories kit was replaced with another of the same, and the procedure was successfully completed.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be good.
 
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Brand Name
SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES
Type of Device
INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6121352
MDR Text Key60691421
Report Number3005099803-2016-03495
Device Sequence Number1
Product Code PGT
UDI-Device Identifier08714729863717
UDI-Public(01)08714729863717(17)20170616(10)0055083008
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,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/01/2016
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-0202
Device Lot Number0055083008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/01/2016
Initial Date FDA Received11/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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