MAUDE Adverse Event Report: TELEFLEX MEDICAL CAPIO; SUTURE, NEEDLE

Catalog Number 833-114

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/19/2016

Event Type  malfunction  

Event Description

During surgery, the surgeons present were using a capio suture device inside of a patient when the bullet broke off into the patient.Due to the small size of the piece that broke off (approximately 3 mm), the surgeons were unable to recover the device.An x-ray was ordered in the pacu, but the piece was not found.

• Brand Name: CAPIO
• Type of Device: SUTURE, NEEDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6124224
• MDR Text Key: 60776130
• Report Number: 6124224
• Device Sequence Number: 1
• Product Code: GAO
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 833-114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2016
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2016
• 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
• Treatment: NO OTHER THERAPIES
• Patient Age: 68 YR
• Patient Weight: 66