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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA Back to Search Results
Model Number FG-0201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Uterine Perforation (2121)
Event Date 02/21/2018
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant reported that the device was not expired.(b)(4).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.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion resecting device was used during a polypectomy procedure performed on (b)(6) 2018.According to the complainant, during procedure and inside the patient, the physician had difficulty dilating and accessing the cervix because it was small and very deep in the pelvis.The physician eventually was able to gain access into the cervix but the visualization of the scope was poor.The resection of the polyp was proceeded for about 20 minutes with very limited visualization.It was noted that the outflow on the tubing turned red with blood.The physician felt she has done enough and the procedure was stopped due to the bleeding.Reportedly, there was either a perforation or false passage.The patient was sent to the main operating room because the physician was not able control the bleeding.The patient condition at the conclusion of the procedure was reported to be poor.Post operatively, the patient was confined in the intensive care unit for a period of time.
 
Manufacturer Narrative
Updated with additional information received on 19mar2018.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion resecting device was used during a polypectomy procedure performed on (b)(6) 2018.According to the complainant, during procedure and inside the patient, the physician had difficulty dilating and accessing the cervix because it was small and very deep in the pelvis.The physician eventually was able to gain access into the cervix but the visualization of the scope was poor.The resection of the polyp was proceeded for about 20 minutes with very limited visualization.It was noted that the outflow on the tubing turned red with blood.The physician felt she has done enough and the procedure was stopped due to the bleeding.Reportedly, there was either a perforation or false passage.The patient was sent to the main operating room because the physician was not able control the bleeding.The patient condition at the conclusion of the procedure was reported to be poor.Post operatively, the patient was confined in the intensive care unit for a period of time.Additional information received on 19mar2018.The physician believed that she resected and perforated the bowel and resulted in resecting a large vein.A vascular surgeon was called to repair the vein in the operating room and the patient received blood transfusion.The patient has been discharged from the hospital after spending some time in the intensive care unit.
 
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Brand Name
SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE
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 Key7344598
MDR Text Key102585731
Report Number3005099803-2018-00829
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,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberFG-0201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
Patient Age48 YR
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