MAUDE Adverse Event Report: US SURGICAL PUERTO RICO SPACEMAKER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SMBTTRNDX

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during totally extraperitoneal bilateral hernia repair, while pumping the dissection balloon, the shaft of trocar leaks and the balloon did not inflate.A new sterile device was unpacked to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the circular seal for the dissector balloon had a hole.The inflation syringe was not received.The insufflation bulb was received.The lock collar, trocar balloon and trocar balloon appeared intact.The obturator was received.A functional evaluation found that the trocar balloon was inflated using a test syringe, no leaks detected.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of cut in the dissector balloon may occur when contact is made with a sharp surgical instrument during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPACEMAKER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9466822
• MDR Text Key: 170707559
• Report Number: 2647580-2019-06133
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521545304
• UDI-Public: 10884521545304
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: SMBTTRNDX
• Device Catalogue Number: SMBTTRNDX
• Device Lot Number: P9G1207Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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