MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON; CUTTER/STAPLER

Model Number PVI35A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/20/2016

Event Type  Injury  

Event Description

Surgeon was using an ethicon powered stapler to dissect the main branch of the pulmonary artery during a thoracotomy.When the stapler was initiated to cut and staple the blade of the stapler pushed the artery rather than making a clean cut causing the staples to not seat properly.

• Brand Name: ETHICON
• Type of Device: CUTTER/STAPLER
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC. ; cincinnati OH
• MDR Report Key: 5669380
• MDR Text Key: 45718997
• Report Number: 5669380
• Device Sequence Number: 0
• Product Code: GDW
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PVI35A
• Device Lot Number: N90W6Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2016
• Distributor Facility Aware Date: 04/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2016
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 71