MAUDE Adverse Event Report: COVIDIEN SPACEMAKER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SMBTTOVLX

Device Problems Defective Device (2588); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 11/04/2016

Event Type  malfunction  

Event Description

Covidien spacemaker pro access and dissector system (10 ml-12mm; reference #: smbttovlx) was defective and unable to open intraoperatively.

• Brand Name: SPACEMAKER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 6213517
• MDR Text Key: 63557242
• Report Number: 6213517
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 11/22/2016,12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SMBTTOVLX
• Device Catalogue Number: SMBTTOVLX
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR