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

Model Number SMBTTRNDX

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/18/2018

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 dissection on a laparoscopic inguinal hernia repair procedure, the obturator handle snapped off.They remove the trocar to remove the obturator and then replaced the trocar to resolve the issue in order 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 first returned product noted that the inflation syringe was not received.The insufflation bulb not was received.The obturator top was disengaged.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 were detected.The trocar balloon was inflated using a test syringe, no leak was 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.

• 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: 7660323
• MDR Text Key: 113272736
• Report Number: 2647580-2018-03296
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521545304
• UDI-Public: 10884521545304
• 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
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: SMBTTRNDX
• Device Catalogue Number: SMBTTRNDX
• Device Lot Number: P6M0061X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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
• Patient Age: 61 YR