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

Model Number SMBTTOVLX

Device Problem Inflation Problem (1310)

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

Event Date 08/23/2018

Event Type  malfunction  

Event Description

Covidien spacemaker pro access and dissector system was open and to be used to access the laparoscopic inguinal hernia repair procedure and the balloon would not inflate after insertion into patient.

• Brand Name: SPACEMAKER
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8084273
• MDR Text Key: 127561584
• Report Number: 8084273
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• 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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA