MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. 3/16INCH TROCAR W/DRAINHAEMONETICS

Model Number H1010

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 12/12/2014

Event Type  Injury  

Event Description

Customer reported the trocar broke during surgery, 2nd surgery had to be performed.

• Brand Name: 3/16INCH TROCAR W/DRAINHAEMONETICS
• Type of Device: 3/16INCH TROCAR W/DRAINHAEMONETICS
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: 6945 southbelt dr. se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4476270
• MDR Text Key: 5326419
• Report Number: 1836161-2015-00002
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H1010
• Device Lot Number: 34323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 01/26/2015
• 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
• Patient Outcome(s): Required Intervention