MAUDE Adverse Event Report: DAVOL, INC. VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM; MESH, SURGICAL, POLYMERIC

Model Number 5955450

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/23/2019

Event Type  malfunction  

Event Description

Mesh was placed through one of the trocars by the doctor.An endoclose device was used to pull the string of the mesh up tight against the abdominal wall then inflated the ring on the echo mesh to help hold the mesh in place.Then a secure strap device was used to tack the mesh in place against the wall.After securing the edges of the mesh, the doctor cut the string holding the inflation ring, so they could finish securing the mesh.The doctor ran into some bleeding from one of the tack sites and used the harmonic scalpel to control it.It took a few minutes to complete.Once the bleeding was under control, the patient was closed.Counts were correct.Patient was extubated and moved onto their bed.Doctor realized we may have left the inflation ring in the patient.We searched the trash and decided it had not been removed from the patient.We set up sterile supplies while the crna re-intubated and went back in to remove the item.Item was removed from patient successfully.

• Brand Name: VENTRALIGHT ST MESH WITH ECHO PS POSITONING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8309873
• MDR Text Key: 135181134
• Report Number: 8309873
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031717
• UDI-Public: (01)00801741031717
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5955450
• Device Catalogue Number: 5955450
• Device Lot Number: HUCP2519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 71