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

Model Number SMBTTOVLX

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

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

Event Date 05/30/2018

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 a laparoscopic inguinal hernia, on placement of the device, the valve seal was damaged.The obturator broke off in the unit.They used another device to complete the case.There was no patient injury.

Manufacturer Narrative

Additional information: evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the first returned product noted that the obturator top was disengaged.The inflation syringe was not received.The insufflation bulb was not received.The lock collar and trocar balloon were received.The dissector balloon appeared intact.Pmv performed functional testing, the dissector balloon was inflated using a test 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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7605607
• MDR Text Key: 111187420
• Report Number: 2647580-2018-02902
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: P7D1179X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 06/21/2018; 08/08/2018
• Supplement Dates FDA Received: 07/16/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• 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