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

Model Number SMBTTOVLX

Device Problem Packaging Problem (3007)

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

Event Date 12/12/2017

Event Type  malfunction  

Event Description

According to the reporter, during a laparoscopic inguinal hernia procedure, while on the removal of the obturator after the insertion of the balloon, the device¿s obturator broke during removal.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 that the obturator top was disengaged.The inflation syringe and insufflation bulb were not received.The lock collar, trocar balloon and dissector balloon appeared intact.Pmv performed functional testing; the hole was covered and the dissector balloon was inflated using a test insufflation bulb, no leaks detected.The trocar balloon was inflated using a test syringe, no leaks detected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the disengaged obturator top may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information becomes available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic inguinal hernia procedure, while on the removal of the obturator after the insertion of the balloon, the device¿s obturator broke during removal.Another device was used in order to complete the case.No patient injury.

• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7152231
• MDR Text Key: 96010027
• Report Number: 2647580-2017-09329
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521545298
• UDI-Public: 10884521545298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: SMBTTOVLX
• Device Catalogue Number: SMBTTOVLX
• Device Lot Number: P7D0038X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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