MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. VESSEL LOOP; VESSEL LOOP, RED, MAXI, NON-STERILE

Model Number 011011NBG

Device Problems Break (1069); Melted (1385); Device Damaged Prior to Use (2284); Material Integrity Problem (2978); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

The product inside of the packaging was stuck together as if the vessel loops had melted together.The customer concern was time used to pull the product apart and at times, the product would break due to the force used to pull apart.Broken pieces could fall into the open cavity of the patient during surgery.No injury was reported.

• Brand Name: VESSEL LOOP
• Type of Device: VESSEL LOOP, RED, MAXI, NON-STERILE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4600444
• MDR Text Key: 5463187
• Report Number: 1836161-2015-00011
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011011NBG
• Device Lot Number: 35763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1