MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYMPHION; RESECTING DEVICE, HYSTEROSCOPE AND ACCESSORIES

Model Number FG-0201

Device Problem Insufficient Information (3190)

Patient Problems Peritonitis (2252); Injury (2348)

Event Date 10/16/2017

Event Type  Injury  

Event Description

Patient underwent submucosal myomectomy with symphion bipolar device on (b)(6).No complications noted, no uterine perforation.Patient presented later with a 1.5cm small bowel injury and enteric peritonitis.Energy of bipolar device escaped the intrauterine cavity and opened the small bowel through the uterine wall, without uterine perforation or direct contact of the bipolar device to the small bowel.Lack of uterine perforation was documented by no evidence of hysteroscopy, no acute loss of deficit on hysteroscopic fluid management; no sign of uterine perforation at the time of the laparotomy by general surgeon and myself, assisting the general surgeon.

• Brand Name: SYMPHION
• Type of Device: RESECTING DEVICE, HYSTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 7006509
• MDR Text Key: 91323761
• Report Number: MW5073157
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2018
• Device Model Number: FG-0201
• Device Lot Number: 62985255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 32 YR
• Patient Weight: 101