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

Model Number SMBTTRNDX

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

Balloon tested in saline and bubbles revealed a hole in balloon.

• Brand Name: SPACEMAKER
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15248577
• MDR Text Key: 298125416
• Report Number: 15248577
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SMBTTRNDX
• Device Catalogue Number: SMBTTRNDX
• Device Lot Number: P2C0194
• 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: 08/10/2022
• Date Report to Manufacturer: 08/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male
• Patient Race: White