MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SYNTHETIC, UROGYNECOLOG, STRESS URINARY, FEMALE, MINI-SLING

Model Number M0068507000

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  malfunction  

Event Description

Trocar did not deploy on the sling when placed.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SYNTHETIC, UROGYNECOLOG, STRESS URINARY, FEMALE, MINI-SLING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10188750
• MDR Text Key: 196240148
• Report Number: 10188750
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068507000
• Device Lot Number: 25051954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1