MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2017

Event Type  malfunction  

Event Description

Surgeon stated he was doing a vaginal suspension using the capio surgical suture device.He noted halfway through passing the prolene stitch that it did not catch, and when he pulled back on the trocar passer the suture popped and a small fraction of the needle (<15mm) stayed in the ligament.

• Brand Name: CAPIO
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7171202
• MDR Text Key: 96610897
• Report Number: 7171202
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2017,12/28/2017

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: No Information
• Other Device ID Number: UPN M0068331240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR