MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD ALLAN VESSEL LOOP

Model Number 3902

Device Problem Break (1069)

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

Event Date 01/30/2014

Event Type  malfunction  

Event Description

Customer reported that multiple packages of this item were opened and tried, and all the loops literally broke apart and are now in pieces.The way it sounded, was that they broke apart during a procedure but did not affect the patient.As soon as the item is released from risk management, they will be sending the affected item back for further evaluation.

• Brand Name: RICHARD ALLAN VESSEL LOOP
• Type of Device: VESSEL LOOP
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 3695465
• MDR Text Key: 19570231
• Report Number: 1836161-2014-00013
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3902
• Device Lot Number: B32722
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• 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