MAUDE Adverse Event Report: ASPEN BARD-PARKER; BLADE, SCALPEL

Catalog Number 371153

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

While using the blade it fell apart into multiple pieces.This caused the surgeon to have to convert the procedure from laparoscopic to open and search the wound for the blade pieces.A piece had to be retained due to not being able to safely retrieve it.

• Brand Name: BARD-PARKER
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN; michelle pulaski; 6945 southbelt drive se; caledonia MI 49316
• MDR Report Key: 7112221
• MDR Text Key: 94666831
• Report Number: 7112221
• Device Sequence Number: 1
• Product Code: GES
• 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: 12/06/2017

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: Physician
• Device Catalogue Number: 371153
• Other Device ID Number: #15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2017
• 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: 18 YR