MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD ALLAN; VESSEL LOOP MINI BLUE STERILE

Model Number 3906

Device Problem Break (1069)

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

Event Date 02/16/2015

Event Type  malfunction  

Event Description

Vessel loop broke in half during procedure.No injury reported and no medical intervention was necessary.Product was in use at the time of failure.There were no notes on what type of procedure was being performed.After complaint was made they removed this lot of vessel loops from stock.

• Brand Name: RICHARD ALLAN
• Type of Device: VESSEL LOOP MINI BLUE STERILE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4613896
• MDR Text Key: 16632550
• Report Number: 1836161-2015-00014
• 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: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3906
• Device Lot Number: 47519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2015
• 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